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Date Job Title Job Level Location
3/5/21 Global Studies Manager Individual contributor South San Francisco, California

At Roche/Genentech Pharma Product Development Operations we are determined to transform drug development and deliver novel medicines with outstanding benefit to patients at lower costs for the society. We want you to join us on this quest and be part of a highly passionate, global and collaborative team who takes pride and energy from challenging the status quo and finding fit for purpose solutions while executing our clinical trials with excellence. Bringing better lives to patients is our core aspiration and is at the heart of each of us while introducing innovation, fostering creativity and being part of high performing teams.

YOUR FOCUS You will be focused on molecules within one of our exciting therapeutic areas in Oncology or I2ON, having the opportunity to experience our multiple areas over time

YOUR TEAM You will report to a Global Studies Leader You will be recognized as a leader and work autonomously in a cross functional, global team

WHAT YOU WILL DO As a Global Studies Manager (GSM) at Roche/Genentech, you will lead or contribute to one or more cross-functional global working groups, expert squads, and global Study Teams, which deliver all operational aspects of one or more studies through all phases and stages. You will:

  • DRIVE OPERATIONAL EXCELLENCE By developing operational plans, creating and managing clinical study budget and overseeing the consistency of operations
  • LEAD AND INFLUENCE By establishing yourself as a leader within the team, being recognized as a thought leader who inspires others to perform at their best and learn from best practices. You’ll be shaping our capabilities and evolving your role overtime
  • PLAN DEMAND AND SUPPLY By overseeing the resource management, forecast and maintenance of supplies needed to ensure sites have the necessary supplies to run clinical studies
  • MANAGE VENDORS AND STAKEHOLDERS By managing relationships with vendors and cross-functional stakeholders. Oversee performance of vendors and third-party providers
  • MANAGE RISK AND COMPLIANCE By developing site monitoring and risk mitigation strategies and ensuring your team adheres to all appropriate standards, including ICH/GCP and other regulations
  • PROVIDE COUNTRY OVERSIGHT By leading feasibility assessments to ensure countries and sites are selected for participation in trials. Provide guidance to country operational reps during trials

HOW YOU WILL DO IT You will succeed as a Global Studies Manager by leading, collaborating, and relaying your expertise to cross-functional partners. You will:

• Apply your good knowledge of drug development process and respective regulations, including ICH and GCP guidelines

 • Apply your organizing and problem-solving skills to plan and run efficient operational aspects of a study

• Motivate others to deliver against commitments, including leadership of global teams across diverse cultures and time zones, embracing diversity and creating a culture of inclusion to ensure successful collaboration

• Demonstrate agility and ability to perform in a highly fast-paced, matrix environment where cross-team collaboration is crucial

• Leverage excellent verbal and written communication skills to motivate your team, negotiate with peers and partners and influence across stakeholders

• Advocate for what you and your team need to succeed

• Model Roche’s values in everything you do

WHO YOU ARE You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, rigorous and entrepreneurial spirit. You…

• Have a growth mindset and are excited about learning through experience

• Feel comfortable thinking on your feet and thrive in fast-paced, ambiguous and highly collaborative environments

• Have a minimum 3 years of relevant experience (clinical trial management is a plus)

• Hold a university degree or equivalent years of experience, preferred focus in life sciences

• A self-starter who finds passion in achieving successful outcomes by leading, directing and inspiring peers

• Want to make a difference and find excitement in innovating practices, products and processes • Possess strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines

At Roche/Genentech, we believe our people are Key to our success in bringing novel medicines to patients and we are fully dedicated to being a great place to work and to provide the services, tools and the environment where everybody feels empowered, trusted and is enabled to uncover his/her true potential. Come join us and help build a diverse and inclusive organization where patient centricity and patient access is a priority.

3/5/21 Senior Scientific Researcher, Viral Vector Core Lab Individual contributor South San Francisco, California

We are seeking a Senior Scientific Researcher to join the Viral Vector Core Lab and contribute to our Translational Genomics efforts. Translational Genomics spans the interface of human genetics, functional genomics, molecular biology, cellular and tissue profiling, disease model engineering, and advanced computational methodology. This group works closely with our disease area scientists to identify new therapeutic hypotheses and advance transformative medicines.

The SSR will work in a fast-evolving and collaborative environment to advance viral vector (Lentivirus, adeno-associated virus, others) technologies and applications in both basic and pre-clinical research.  She/he will work independently to design, produce, and apply research materials that facilitate cutting-edge functional genomic screens, in vivo/somatic genome editing and cell/gene therapy programs. In addition, she/he will provide biosafety guidance and hands-on support for collaborator-driven efforts that span the entirety of Genentech’s research division.

Responsibilities

  • Responsible for virus production, purification, titration and QC.   

  • Responsible for designing, developing and optimizing viral vectors to deliver genetic materials in vitro and in vivo for therapeutic target discovery/validation and animal disease model engineering.

  • Collaborate with  research labs on the application of viral vectors and flow cytometer support. 

  • Assist in the maintenance of core lab facilities. 

  • Contribute to publications in high quality scientific journals and will have the opportunity to present through presentations at key internal and external meetings. 

 

Qualifications

  • The candidate must have a Ph.D. in Molecular Biology, Biochemistry, Genetics, Virology, Cell/Gene Therapy, Cancer Biology, Immunology, Neuroscience, or a related discipline. Post-doctoral or equivalent experience is desirable. 

  • Highly motivated, can lead technology development independently. 

  • Must have experience with one or more of the following areas: 

    • Engineering/Handling/Application of lentivirus, retrovirus, adenovirus, AAV, or other viral vector technologies.

    • CRISPR-Cas9, RNAi, ORF, and other technologies for gene modification/manipulation  in vitro or in vivo

    • Animal handling/surgeries/procedures, animal tissue processing and analysis

  • Experience with Next-Generation Sequencing (NGS), biostatistics, and/or basic bioinformatics is desirable.

  • Excellent interpersonal skills with demonstrated ability to work within a dynamic, collaborative research environment.

  • Excellent oral and written presentation skills.

#LI-JD1

#translationalgenomics

3/4/21 Therapeutic Area Manager (TAM), Lung Pan Tumor - Michigan Ecosystem Individual contributor Michigan

Therapeutic Area Manager (TAM)

Position Overview

From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver ever better health outcomes for patients while lowering overall healthcare costs.

The Therapeutic Area Manager (TAM) is integral to successfully delivering this vision, working closely with healthcare providers. The TAM deeply understands the specific needs of healthcare practitioners in their therapeutic area to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care.

The TAM is empowered to own the business for their TA within the ecosystem and to optimize as appropriate; focused on improving the customer and patient experience across the care continuum. They will leverage other ecosystem and organization experts to provide customers with the information they need about products to make decisions that support enhanced patient outcomes, and to influence the ecosystem business strategy. The TAM will represent all relevant products and indications within the designated Therapeutic Area.

In alignment with the ecosystem and customer strategic plan, the TAM is accountable for driving on-label clinical demand to ensure HCPs identify the right medication for the right patient.

In addition, they are responsible for collecting ecosystem insights and trends and being a primary conduit between an ecosystem, the Squads and marketing to support the national strategy at a local level.  The TAM will represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials.

There are two levels of Therapeutic Area Managers. The difference is based on the scope, complexity and criticality to the ecosystem business as well as differences in expertise required to execute responsibilities.

Key Accountabilities

Serve as primary point of contact for their therapeutic area for their customers in the  ecosystem. Address and identify opportunities for pulling through ecosystem and TA squad strategies at the point-of-care Apply strong understanding of the specific needs of healthcare practitioners and mobilizes ecosystem and organization experts to partner with customers to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care Contribute to the development and execution of customer account plans for target accounts to deliver maximum impact opportunities and business goals Deliver education to HCPs regarding product information, appropriate use, and dosing and administration based on FDA approved product information and formulary/pathways/guidelines (e.g. one on one interactions, in-services, identification of opportunities for peer-to-peer programming, etc.). Effectively triage to USMA experts as appropriate Address product acquisition (contract awareness, etc), and address supply matters through coordination of distribution issues, and managing spoilage and returns Ensure product access to provide proactive (and de-identified) education on patient assistance, reimbursement resources. Triage to HD and FRM as appropriate Keep abreast of customer and healthcare industry trends. Initiates development actions to constantly adapt and grow capabilities to increase impact Represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials Lead, act and live our Operating Principles in all aspects of work

Qualifications

  • Scientific or clinical degree, Bachelor’s degree level at minimum
  • Previous cross-functional industry experience in commercial life sciences (pharma or biotechnology) or related industry engaging with key healthcare ecosystem players (e.g., payers, health systems), is required
  • 4 or more years experience working in a sales role with HCPs, ideally representing multiple products and working across a complex healthcare system environment
  • Clinical nurse or Advanced Practice Nurse (APN) experience highly valued
  • Ability to work in an ambiguous environment undergoing transformation is a strong plus
  • Proven track record in coaching, training and/or mentoring peers or others as assigned; helping such others to better meet or exceed their goals, targets and other responsibilities
  • Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals
  • Self starter; ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem
  • Ability to assimilate and communicate complex clinical and product information
  • Knowledge of and ability to successfully addressing operational issues in the delivery of healthcare products to patients, such as reimbursement and supply
  • Understanding of external laws, codes and company policies that apply to the healthcare industry

CMG Operating Principles

I put the patient first, always.

I am tenacious in meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive. 

I build a culture of trust.

I grow my capabilities to increase my impact.

I have a bias for action.

I am accountable.

I use time and resources to create the most impact.

I act with integrity.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

It is highly preferred the candidate live within the ecosystem.

Colorado applicants are not eligible. 

This is a field-based position and overnight travel may be required. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

3/4/21 Medical Affairs Executive Director, Mega National Accounts (Remote) Manager without direct reports California

Medical Affairs Executive Director, Mega National Accounts

Position Overview

From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver ever better health outcomes for patients while lowering overall healthcare costs.

The Medical Affairs Executive Director, Mega National Accounts is a cross-portfolio role, accountable for co-creating and driving an overarching medical strategy across organizations with national scope, including Payers, Federal, National Comprehensive Cancer Network / pathway vendors, Channel, Hospital and Distribution customers with the goal of shaping strategies for optimized access and formulary positioning of Genentech products while at the same time seeking to improve patient outcomes and customer experience. In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.

The Medical Affairs Executive Director, Mega National Accounts will have field accountability for key customers and will be responsible for collaborating closely with MED roles focused on local healthcare regions to gain alignment and execute against shared medical goals and ensure national decisions are pulled through at the local level. The Medical Affairs Executive Director, Mega National Accounts will work in close partnership with their commercial National Accounts counterparts to ensure shared accountability across the designated accounts, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience. The Medical Affairs Executive Director, Mega National Accounts is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their team.

The Medical Affairs Executive Director, Mega National Accounts will provide medical leadership for defined teams to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value.

Key Accountabilities:

1. Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs

2. Connect with key medical customers to co-create solutions leveraging Genentech/Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum

3. Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products

4. Define the strategic near and long-term medical vision and direction for the defined National Accounts in order to identify opportunities for collaboration which enhance patient outcomes and experience

5. Lead and influence national field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across the nation

6. Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities:

● Primary medical point of contact for defined National Accounts to co-create, prioritize,

plan, and implement mutual beneficial, cross portfolio or population health initiatives that

are aligned with account and U.S. Medical Affairs (USMA) priorities

● Lead development and execution of medical strategy and vision (with local healthcare

region medical partners) aligned with the broader organization and provide ongoing

visibility of account plans to all relevant stakeholders

● Foster amongst team ongoing awareness of cross-functional disease area leadership

team and USMA objectives and strategy to integrate into account plans across the

nation

● As needed, facilitate and coordinate Therapeutic Area MSL (TA MSL) touchpoints to

optimize medical engagements with defined National Accounts customers. Partner with

TA MSLs for discussions that require deep scientific, technical expertise

● Help determine allocation of resources and make investment decisions to maximize

patient outcomes and customer engagement while delivering value for Genentech

● Ability to provide high level scientific engagement across the Genentech portfolio of

products, to include pipeline presentations across all key disease and therapeutic areas

● In partnership with the commercial National Accounts team, establish and manage

senior stakeholders and C-suite relationships across the defined National Accounts in

order to better understand their needs and identify insights and opportunities for medical

collaboration

● Identify and co-create research collaboration opportunities across National Accounts

customers to address key questions in the delivery of patient care

● In conjunction with the National Accounts field team:

● Identify and establish health outcomes and RWE collaborations that leverage

capabilities of the nation

● Identify scientific research priorities with local healthcare region medical partners,

other national health services researchers, or through appropriate internal

stakeholders (medical teams, health outcomes research teams, development,

etc.)

● Collaborate with commercial National Accounts team to ensure appropriate triage

of commercial opportunities while leveraging medical staff for appropriate

discussions and support  

● Support national healthcare market opportunities (e.g., Oncology Care Model)

● Represent cross portfolio customer needs, insights and knowledge to other parts of

Genentech including senior leadership and other internal partners (i.e. cross-functional

disease area leadership team, medical teams, health outcomes research teams, etc.) in

order to advance shared goals between Genentech and the customer

● Identify, facilitate, and pull through training needs for defined National Accounts team

and beyond to ensure team members are competent in evolving market landscape

● Track National Accounts customer experience, both formally and informally, and use this

information to enhance customer engagement and medical strategy

● Develop and track metrics across the medical portfolio in partnership with commercial

National Accounts team, when appropriate to include – total number of clinical trials by

disease area, performance across clinical trials, delivery on research initiatives, clinical

pathway and guideline implementation and utilization, formulary status, etc. Identify

opportunities through analytics and ongoing business reviews and using agile

approaches to adapt medical plans where required

● Create and foster a culture that is collaborative and customer centric, and a team that is

curious about possibility and empowered for action

● Lead change and encourage a mindset of experimentation and innovation to continually

refresh and enhance the customer experience

● Attend and represent Genentech through advisory panels, advisory boards and other

professional and/or policy-making forums to influence the healthcare debate and

advance Genentech’s mission to be the leading biotechnology company in the U.S.

● Comply with all laws, regulations and policies that govern the conduct of Genentech

activities

●This position may be accountable for covering more than one National Account pending

business needs

Qualifications

● Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA,

etc.)

● 10 years related work experience strongly preferred (managed care/health plan, hospital

administration, clinical pathway or formulary decision maker, industry experience, etc)

with demonstrable evidence of successfully partnering with customers and achieving

shared goals and outcomes

● Developing and implementing strategy across complex healthcare environments with an

ability to influence without authority and mobilize colleagues to action around shared

goals

● Ability to lead complex cross-functional account teams and operating under ambiguity

without a set playbook, including aligning teams

● Strong ability to lead, influence, and work in a matrixed environment regardless of

reporting structure

● Ongoing investment in developing self and others to enable others to achieve their

potential, deliver ambitious goals or achieve excellence

● Excellent understanding of external laws, codes and company policies that apply to the

healthcare industry

Genentech Operating Principles

● I put the patient first, always.

● I am obsessed with meeting customer needs.

● I act on behalf of the whole company, not just my team.

● I am inclusive.

● I build a culture of trust.

● I have a growth mindset.

● I act with urgency.

● I am accountable.

● I radically simplify & prioritize for impact.

● I follow the science.

● I build our reputation.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

This position requires significant driving of either a company provided or personal vehicle as

well as prolonged periods of sitting, both of which are part of the essential duties and

responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

This is a field-based position. Must be willing to travel overnight to meet with customers, internal stakeholders, and attend relevant conferences up to 70% time.

Colorado applicants are not eligible.

#LI-Remote

#LI-CG2

3/4/21 Scientist, OMNI Biomarker Development Individual contributor South San Francisco, California

Who We Are

The OMNI-Biomarker Development department at Genentech provides translational science support to inform the clinical development of novel personalized therapeutics in disease areas of Ophthalmology, Metabolism, Neuroscience, Immunology and Infectious Diseases (OMNI). Our biomarker strategies are designed to study the molecular pathways driving the disease and to establish the mechanism of action of our therapeutics. We focus on prognostic, predictive and pharmacodynamic biomarkers to enable our vision of “the right drug for the right patient at the right dose.”

The Position

We are seeking a highly motivated Scientist to join the OMNI-Biomarker Development Department within Development Sciences to drive our biomarker and drug development efforts in multiple sclerosis. Our department is responsible for defining biomarker and personalized healthcare strategies, designing and implementing biomarker assays in clinical trials, and interpreting biomarker results. Our group uses relevant biomarkers to evaluate disease heterogeneity, target-engagement, mechanism of action, and disease modification; and to guide clinical diagnostic biomarker development. Biomarker team leaders within the department provide scientific leadership for biomarkers in clinical trials ranging from early proof-of-concept through marketed products.

Responsibilities

The successful candidate will join our dynamic team and work to identify biomarkers in support of drug development projects in multiple sclerosis.  The candidate will support multiple trials, lead efforts for data generation and analyses within internal studies and as part of external academic collaborations relating to understanding biomarkers in multiple sclerosis. The successful Scientist will have the opportunity to grow into a project biomarker team leader. Success in these responsibilities requires a thorough understanding of disease and drug target biology, creativity and attention to detail, and experience in integrating biomarkers into clinical trials. Candidates familiar with molecular/immunological techniques and analytic methods including immunoassay, qPCR, genetics, gene expression analysis, cellular immunology, or analytics (knowledge of R or other data analysis programming experience) will be given preference. The position requires working in close partnership across various functions including Research, Bioanalytical Assay Department, Diagnostics, Clinical Sciences, Biostatistics, Bioinformatics, Regulatory and with external partners. Effective communication is essential and includes presentations at cross-functional teams, internal review committees, and external conferences, and will also involve writing biomarker sections of clinical protocols, reports, regulatory filings and scientific publications.

Who You Are

Candidates must have a PhD or MD in Neurology, Neuroscience and/or Immunology, or a related field with at least 2 years of post-doctoral or fellowship experience in basic or translational research either in an academic and/or industry setting.  The candidate must demonstrate a high level of independence and be able to develop hypotheses and direct analysis plans. Strong writing and communication skills are required, as evidenced by publications, meeting abstracts and/or drug development reports. We are looking for an individual who would be passionate about using their understanding of disease biology to make impactful contributions to clinical drug development. Willingness to collaborate across time zones including our Swiss site is a must.  Preferred candidates will have prior experience in multiple sclerosis and a demonstrated ability to function as part of a cross-functional team such as research or clinical trial project teams.

#LI-GENEKC1

3/4/21 BioAnalytical Manager Individual contributor South San Francisco, California

BioAnalytical Operations translates and applies strategy and innovation for bioanalysis and immunogenicity into clinical and non-clinical studies. Through global collaboration and robust portfolio management, our team brings technical and operational expertise along with passion and drive to make a difference for patients.

Job Scope:

The BioAnalytical Manager (BAM) provides bioanalytical operational expertise to local (PET) and global (SMT) clinical study teams to implement and execute strategies for anti-drug antibody (ADA) and pharmacokinetic (PK) analysis for all phases of clinical studies for Genentech programs. The BAM serves as a single point of contact between scientific functions (BAS, Clinical Pharmacology, DMPK), CROs, and clinical study teams for each clinical study to operationalize sample collection logistics, execute bioanalysis, and facilitate timely delivery of data to internal stakeholders and clinical study teams.

Primary Responsibilities:

May work with pharmacology sub-teams to provide input on PK/ADA deliverable timing, PVC input during PAR team review, and to understand clinical program development direction (filings, new studies) to ensure program needs are met.

Develops and maintains effective, collaborative relationships with study teams, scientific function key stakeholders, data groups, internal outsourcing contacts, and CROs. Harmonizes sample collection and handling instructions per bioanalytical strategies and assay requirements to ensure they are included in clinical site lab manual. Facilitate resolution of sample and data discrepancies and disposition of samples throughout the study lifecycle. Authors and reviews relevant sections of study related documents (i.e., central lab SOWs, study protocols/ICFs, bioanalytical reports, etc.).

Develops study-specific sample and data flows plans with stakeholders (e.g. BAMP). Develops and manages timelines for bioanalytical labs to ensure samples are tested according to protocol and data is transferred in the specified format per study team timelines.

Assists function with outside spend (PVC) budget planning and management of actual spend (invoices, PO) for studies.

Contributes to identification of bioanalysis CROs and set up of contracts for bioanalysis, working with internal contacts. Through CRO Central Point of Contact (CPoC), manage CRO deliverables and performance, ensuring all deliverables are met per SOWs and study timelines. Provide inputs on CRO performance, escalating concerns as appropriate.

May assist with training and participate on organizational initiatives to support business needs. Applies relevant regulatory compliance and internal business standards in the performance of job responsibilities (e.g. eTMF, RACT, Maintenance of Study Tracking Documentation).

Education and Experience Requirements:

Bachelor’s degree or higher in biology, chemistry, or related scientific discipline. Project management certification desirable.

8-11 years of professional experience in pharmaceutical or biotechnology industry that includes experience related to bioanalysis and sample handling, CRO management, and/or clinical development/operations.

Working knowledge of ICH GCP.

Skills:

Highly effective verbal and written communication.

Ability to make sound decisions with limited information in a changing landscape, influence, and negotiate effectively, using appropriate judgement.

Highly motivated and proactive in performing work independently with a problem-solving mindset.

Demonstrated evidence of successful collaboration and delivery of results in a highly matrixed organization, working with culturally and geographically diverse teams.

Excellent organization and project management skills with high attention to detail to independently manage multiple projects with competing priorities.

#DevSci

#LI-HB2

3/4/21 Senior Scientific Researcher, Protein Biochemist, Peptide Discovery Individual contributor South San Francisco, California

We’re looking for an experienced protein biochemist, chemist, or chemical biologist to join our group within the Department of Early Discovery Biochemistry. The group utilizes multidisciplinary tools for target validation across different therapeutic areas including oncology, immunology, and ophthalmology. Recent efforts focus on modulating protein-protein interactions and the study of cell-penetrating peptides. The successful candidate will be responsible for discovering and producing proteins and peptides of therapeutic interest. Additionally, the researcher will characterize such molecules by standard analytical methods and assess their functional mechanisms using biochemical and biophysical assays. This is a basic research position that requires critical thinking, flexibility, multitasking, and the ability to learn new techniques.

Requirements

  • Ph.D. in biochemistry, chemistry, chemical biology, or a related discipline working extensively with proteins and/or peptides.  
  • Experience in: protein expression and purification (affinity, ion exchange, size exclusion, and/or HPLC); standard protein and peptide analytical methods (SDS-PAGE and western analysis); biochemical and biophysical assays; construct design and molecular biology.
  • Can work both independently and collaboratively, and is highly team-oriented.
  • Has strong analytical, organizational, and communication skills.
  • Sustained record of productivity as evidenced by publications in top-tier journals or patent inventorships.

Preferred Qualities

  • Experience with library display technologies (phage, mRNA, yeast).
  • Previous experience with conjugation reactions or other chemical modifications of proteins.
  • A deep understanding of the chemical and molecular principles that drive protein interactions, as well as the ability to model these interactions using appropriate software.

#LI-LM1

3/4/21 Case Monitoring and Resolution Engineer Individual contributor Barcelona

At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. 

Our success is built on innovation, curiosity and diversity. Roche is one of the highest spender on research and development (R&D) among global pharmaceuticals, spending more than 20% of revenue. This substantial investment has resulted in products that have advanced the understanding of disease and transformed the practice of medicine. 

At the same time, sustainability is an integral part of Roche’s business. We are committed to mitigate environmental impact and climate change, proactively seeking new, more sustainable technologies to achieve this goal. For the eleventh time, Roche has been recognised as the most sustainable company in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI).

We recognize the importance of work-life balance and personal well-being, considering flexible working options, including remote working, and respecting personal downtime for all roles. We strive to provide our employees with the best possible work environment. For many years, Roche has been consistently ranked as a great place to work by its employees and by external institutions. Furthermore, we are proud to be an equal opportunity employer, offering extensive training and development opportunities that enable all people to bring their unique selves to Roche. 

At Case Investigation and Resolution (CIR) department, you will learn about laboratory automation and software solutions, as well as varied regulatory requirements and quality practices in the area of medical technology. In this challenging department, you will have freedom for innovation and creativity. In addition, you will have autonomy and flexibility in how to approach your day-to-day tasks, mentored and guided by more senior members of the team. At CIR, we strive for an agile mindset in our daily work, focusing on achieving the best for patients and continuously working on improving our solutions. 

Details of the position

Main tasks:

- Assumes responsability under the supervision of a Senior member of the team for the management of individual cases (Inquiries, Complaints) in the area assigned according to regulatory and ISO Quality system requirements and needs of the Country Organizations in a timely manner.

- Resolves cases in the assigned area, potentially requiring consultation with more senior team members on technical or process-related aspects.

- Pro-actively consults / involves a more senior team member in cases not following pre-determined / prescribed process.

- Performs correct processing and documentation for individual cases in the area assigned.

- Cases need to be auditable and well documented to be self-explanatory to a person who has no specialized product or process knowledge (e.g. in an audit).

- Could represent and communicate result of individual case/issue in interfacing meetings.

- Assumes responsibility for providing information from cases in order to update product documentation.

Additional tasks:

- Contributes to initial and continuous knowledge transfer from manufacturer, R&D or GCS for new products in the project phase to ensure availability of comprehensive system knowledge.

- Ensures knowledge transfer to new employees.

- Could contribute in task forces for individual case/issue in their area of competency.

- Permanently optimizes processes to increase quality and efficiency standards with focus on customer, compliance and continuous improvement.

- Browse the code repository and consult source code files when required to ensure a correct investigation but never making any modifications in the repository or the checked-in source code.

Requirements:

Education:

- Graduate Degree from a University of Applied Sciences or from a Professional Education and Training (PET) College (Higher Technical Schools) or equivalent professional experience.

- Vocational training in technical area completed with Federal Vocational Baccalaureate and several years of work experience

Competencies (skills and behaviors required):

- Sound technical product knowledge and principle of operation:

- intended use

- customer workflow

- principle of assay, system functionality

- Good appreciation of how product is used by the customer and their environment

- Basic understanding of business context for the products assigned

- Process Knowledge: full understanding

- Versed in the technology, at the level required to be able to converse with a 1st level representative of an Affiliate who already investigated and raised the issue to global

- Ability to apply troubleshooting / problem solving methodology

- Ability to draw conclusions on individual cases, potentially requiring consultation with Senior Scientist / Engineer or Principal

- Ability to effectively communicate with interfaces (e.g. Affiliates, Safety Board, R&D Experts)

- Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP).

- Main focus lies on the cobas infinity IT solution

Languages:

-Strong communication skills in English (written and spoken) are essential

- Knowledge of other languages is a plus

Specific Requirements (Job related experience):

- Work experience in the area of medical technology in either 1st or 2nd level support or R&D related functions

- Knowledge of the diagnostic market is desired

- Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485)

Travel Requirements:

Approximately 5-10% of time

Working for Roche means more than just having a job. Guided by integrity, courage and passion, working for Roche means innovating diagnostics, shaping healthcare and changing lives. Apply now and be part of our team!

3/4/21 Medical Affairs Executive Director - CA, HI (Ecosystem) Remote Manager without direct reports California

Position Overview

The Medical Affairs Executive Director (MED) - CA, HI (Ecosystem) is a cross portfolio role,  responsible for co-creating and driving an overarching medical strategy across a local healthcare region with the goal of improving patient outcomes and customer experience.  In collaboration with other field partners, the MED will develop a deep understanding of the local healthcare region across health systems, payers, and other key influencers in the region.  In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.  The MED will have field accountability with key customers in the ecosystem and will be responsible for collaborating closely with therapeutic area MSLs (TA MSLs) within the same region to gain alignment and execute against shared medical goals. The MED will work in close partnership with their commercial counterpart, the Healthcare Market Executive Director (HED), to ensure shared accountability across the designated region, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience.  The MED is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their region’s team. 

The MED will provide medical leadership for a defined region’s team to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value. 



Key Accountabilities

  • Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs
  • Connect with key medical customers to co-create solutions leveraging Genentech/ Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum.
  • Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products  
  • Define the strategic near and long-term medical vision and direction for the healthcare region in order to identify opportunities for collaboration which enhance patient outcomes and experience
  • Lead and influence regional field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across regions
  • Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities 

  • Primary medical point of contact for large customers in their region to co-create, prioritize, plan, and implement mutual beneficial, cross portfolio or population health initiatives that are aligned with account and U.S. Medical Affairs (USMA) priorities
  • Lead development and execution of medical strategy and vision (with TA MSLs) aligned with the broader organization and provide ongoing visibility of account plans to all relevant stakeholders
  • Foster amongst team ongoing awareness of the cross-functional disease area leadership team and USMA objectives and strategy to integrate into account plans across the region
  • As needed, facilitate and coordinate TA MSL touchpoints to optimize medical engagements with shared region customers.  Partner with TA MSLs for discussions that require deep scientific, technical expertise
  • Help determine allocation of resources and make investment decisions to maximize patient outcomes and customer engagement while delivering value for Genentech
  • Ability to provide high level scientific engagement across the Genentech portfolio of products, to include pipeline presentations across all key disease and therapeutic areas
  • In partnership with the HED, establish and manage senior stakeholders and C-suite relationships across the region in order to better understand their needs and identify insights and opportunities for medical collaboration
  • Identify and co-create research collaboration opportunities across customers within a region to address key questions in the delivery of patient care
  • In conjunction with the region’s field team:
    • Identify and establish health outcomes and RWE collaborations that leverage capabilities of the region
    • Identify scientific research priorities with TA MSLs, other region health services researchers, or through appropriate internal stakeholders (medical teams, health outcomes research teams, development, etc.)
    • Collaborates with HED to ensure appropriate triage of commercial opportunities while leveraging medical staff for appropriate discussions and support  
    • Supports geographic or local healthcare market opportunities (e.g., Oncology Care Model)
  • Represent cross portfolio customer needs, insights and knowledge to other parts of Genentech including senior leadership and other internal partners (i.e. cross-functional disease area leadership team, medical teams, health outcomes research team, etc.) in order to advance shared goals between Genentech and the customer.  
  • Identify, facilitate, and pull through training needs for the region field medical partners and beyond to ensure team members are competent in evolving market landscape
  • Track the region’s customer experience, both formally and informally, and use this information to enhance customer engagement and medical strategy 
  • Develop and track metrics across the medical portfolio in partnership with HED, when appropriate to include – total number of clinical trials by disease area, performance across clinical trials, delivery on research initiatives, clinical pathway and guideline implementation and utilization, formulary status, etc.  Identify opportunities through analytics and ongoing business reviews and using agile approaches to adapt medical plans where required  
  • Create and foster a culture that is collaborative and customer centric, and a team that is curious about possibility and empowered for action  
  • This position will have direct accountability for providing coaching and feedback to their region partners.  In some regions depending on size, complexity, and geography, this position could be a role with management responsibilities for field medical personnel in the region
  • Lead change and encourage a mindset of experimentation and innovation to continually refresh and enhance the customer experience 
  • This position may be accountable for covering more than one healthcare region pending business needs

Qualifications

  • Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.)
  • 10 years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with demonstrable evidence of successfully partnering with customers and achieving shared goals and outcomes
  • Developing and implementing strategy across complex healthcare environments with an ability to influence without authority and mobilize colleagues to action around shared goals
  • Ability to lead complex cross-functional account teams and operating under ambiguity without a set playbook, including aligning teams
  • Strong ability to lead, influence, and work in a matrixed environment regardless of reporting structure
  • Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
  • Excellent understanding of external laws, codes and company policies that apply to the healthcare industry

Genentech’s Operating Principles

I put the patient first, always. 

I am obsessed with meeting customer needs.

I act on behalf of the whole company, not just my team. 

I am inclusive.  

I build a culture of trust. 

I have a growth mindset.

I act with urgency.

I am accountable.

I radically simplify & prioritize for impact.

I follow the science.

I build our reputation.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

 It is highly preferred the candidate live within the region.  

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

Colorado applicants are not eligible.

#LI-CG2

#LI-Remote

3/4/21 Medical Affairs Executive Director - New York Metro (Ecosystem) Remote Manager without direct reports New York

Position Overview

The Medical Affairs Executive Director (MED) is a cross portfolio role,  responsible for co-creating and driving an overarching medical strategy across a local healthcare region with the goal of improving patient outcomes and customer experience.  In collaboration with other field partners, the MED will develop a deep understanding of the local healthcare region across health systems, payers, and other key influencers in the region.  In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.  The MED will have field accountability with key customers in the ecosystem and will be responsible for collaborating closely with therapeutic area MSLs (TA MSLs) within the same region to gain alignment and execute against shared medical goals. The MED will work in close partnership with their commercial counterpart, the Healthcare Market Executive Director (HED), to ensure shared accountability across the designated region, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience.  The MED is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their region’s team. 

The MED will provide medical leadership for a defined region’s team to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value. 



Key Accountabilities

  • Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs
  • Connect with key medical customers to co-create solutions leveraging Genentech/ Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum.
  • Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products  
  • Define the strategic near and long-term medical vision and direction for the healthcare region in order to identify opportunities for collaboration which enhance patient outcomes and experience
  • Lead and influence regional field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across regions
  • Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities 

  • Primary medical point of contact for large customers in their region to co-create, prioritize, plan, and implement mutual beneficial, cross portfolio or population health initiatives that are aligned with account and U.S. Medical Affairs (USMA) priorities
  • Lead development and execution of medical strategy and vision (with TA MSLs) aligned with the broader organization and provide ongoing visibility of account plans to all relevant stakeholders
  • Foster amongst team ongoing awareness of the cross-functional disease area leadership team and USMA objectives and strategy to integrate into account plans across the region
  • As needed, facilitate and coordinate TA MSL touchpoints to optimize medical engagements with shared region customers.  Partner with TA MSLs for discussions that require deep scientific, technical expertise
  • Help determine allocation of resources and make investment decisions to maximize patient outcomes and customer engagement while delivering value for Genentech
  • Ability to provide high level scientific engagement across the Genentech portfolio of products, to include pipeline presentations across all key disease and therapeutic areas
  • In partnership with the HED, establish and manage senior stakeholders and C-suite relationships across the region in order to better understand their needs and identify insights and opportunities for medical collaboration
  • Identify and co-create research collaboration opportunities across customers within a region to address key questions in the delivery of patient care
  • In conjunction with the region’s field team:
    • Identify and establish health outcomes and RWE collaborations that leverage capabilities of the region
    • Identify scientific research priorities with TA MSLs, other region health services researchers, or through appropriate internal stakeholders (medical teams, health outcomes research teams, development, etc.)
    • Collaborates with HED to ensure appropriate triage of commercial opportunities while leveraging medical staff for appropriate discussions and support  
    • Supports geographic or local healthcare market opportunities (e.g., Oncology Care Model)
  • Represent cross portfolio customer needs, insights and knowledge to other parts of Genentech including senior leadership and other internal partners (i.e. cross-functional disease area leadership team, medical teams, health outcomes research team, etc.) in order to advance shared goals between Genentech and the customer.  
  • Identify, facilitate, and pull through training needs for the region field medical partners and beyond to ensure team members are competent in evolving market landscape
  • Track the region’s customer experience, both formally and informally, and use this information to enhance customer engagement and medical strategy 
  • Develop and track metrics across the medical portfolio in partnership with HED, when appropriate to include – total number of clinical trials by disease area, performance across clinical trials, delivery on research initiatives, clinical pathway and guideline implementation and utilization, formulary status, etc.  Identify opportunities through analytics and ongoing business reviews and using agile approaches to adapt medical plans where required  
  • Create and foster a culture that is collaborative and customer centric, and a team that is curious about possibility and empowered for action  
  • This position will have direct accountability for providing coaching and feedback to their region partners.  In some regions depending on size, complexity, and geography, this position could be a role with management responsibilities for field medical personnel in the region
  • Lead change and encourage a mindset of experimentation and innovation to continually refresh and enhance the customer experience 
  • This position may be accountable for covering more than one healthcare region pending business needs

Qualifications

  • Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.)
  • 10 years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with demonstrable evidence of successfully partnering with customers and achieving shared goals and outcomes
  • Developing and implementing strategy across complex healthcare environments with an ability to influence without authority and mobilize colleagues to action around shared goals
  • Ability to lead complex cross-functional account teams and operating under ambiguity without a set playbook, including aligning teams
  • Strong ability to lead, influence, and work in a matrixed environment regardless of reporting structure
  • Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
  • Excellent understanding of external laws, codes and company policies that apply to the healthcare industry

CMG Operating Principles

● I put the patient first, always.

● I am obsessed with meeting customer needs.

● I act on behalf of the whole company, not just my team.

● I am inclusive.

● I build a culture of trust.

● I have a growth mindset.

● I act with urgency.

● I am accountable.

● I radically simplify and prioritize for impact.

● I follow the science.

● I build our reputation. 

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

 It is highly preferred the candidate live within the region.  

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

Colorado applicants are not eligible.

#LI-CG2

#LI-Remote

3/4/21 Medical Affairs Executive Director - Eastern New England (Ecosystem) Remote Manager without direct reports Massachusetts

Position Overview

The Medical Affairs Executive Director (MED) is a cross portfolio role,  responsible for co-creating and driving an overarching medical strategy across a local healthcare region with the goal of improving patient outcomes and customer experience.  In collaboration with other field partners, the MED will develop a deep understanding of the local healthcare region across health systems, payers, and other key influencers in the region.  In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.  The MED will have field accountability with key customers in the ecosystem and will be responsible for collaborating closely with therapeutic area MSLs (TA MSLs) within the same region to gain alignment and execute against shared medical goals. The MED will work in close partnership with their commercial counterpart, the Healthcare Market Executive Director (HED), to ensure shared accountability across the designated region, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience.  The MED is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their region’s team. 

The MED will provide medical leadership for a defined region’s team to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value. 



Key Accountabilities

  • Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs
  • Connect with key medical customers to co-create solutions leveraging Genentech/ Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum.
  • Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products  
  • Define the strategic near and long-term medical vision and direction for the healthcare region in order to identify opportunities for collaboration which enhance patient outcomes and experience
  • Lead and influence regional field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across regions
  • Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities 

  • Primary medical point of contact for large customers in their region to co-create, prioritize, plan, and implement mutual beneficial, cross portfolio or population health initiatives that are aligned with account and U.S. Medical Affairs (USMA) priorities
  • Lead development and execution of medical strategy and vision (with TA MSLs) aligned with the broader organization and provide ongoing visibility of account plans to all relevant stakeholders
  • Foster amongst team ongoing awareness of the cross-functional disease area leadership team and USMA objectives and strategy to integrate into account plans across the region
  • As needed, facilitate and coordinate TA MSL touchpoints to optimize medical engagements with shared region customers.  Partner with TA MSLs for discussions that require deep scientific, technical expertise
  • Help determine allocation of resources and make investment decisions to maximize patient outcomes and customer engagement while delivering value for Genentech
  • Ability to provide high level scientific engagement across the Genentech portfolio of products, to include pipeline presentations across all key disease and therapeutic areas
  • In partnership with the HED, establish and manage senior stakeholders and C-suite relationships across the region in order to better understand their needs and identify insights and opportunities for medical collaboration
  • Identify and co-create research collaboration opportunities across customers within a region to address key questions in the delivery of patient care
  • In conjunction with the region’s field team:
    • Identify and establish health outcomes and RWE collaborations that leverage capabilities of the region
    • Identify scientific research priorities with TA MSLs, other region health services researchers, or through appropriate internal stakeholders (medical teams, health outcomes research teams, development, etc.)
    • Collaborates with HED to ensure appropriate triage of commercial opportunities while leveraging medical staff for appropriate discussions and support  
    • Supports geographic or local healthcare market opportunities (e.g., Oncology Care Model)
  • Represent cross portfolio customer needs, insights and knowledge to other parts of Genentech including senior leadership and other internal partners (i.e. cross-functional disease area leadership team, medical teams, health outcomes research team, etc.) in order to advance shared goals between Genentech and the customer.  
  • Identify, facilitate, and pull through training needs for the region field medical partners and beyond to ensure team members are competent in evolving market landscape
  • Track the region’s customer experience, both formally and informally, and use this information to enhance customer engagement and medical strategy 
  • Develop and track metrics across the medical portfolio in partnership with HED, when appropriate to include – total number of clinical trials by disease area, performance across clinical trials, delivery on research initiatives, clinical pathway and guideline implementation and utilization, formulary status, etc.  Identify opportunities through analytics and ongoing business reviews and using agile approaches to adapt medical plans where required  
  • Create and foster a culture that is collaborative and customer centric, and a team that is curious about possibility and empowered for action  
  • This position will have direct accountability for providing coaching and feedback to their region partners.  In some regions depending on size, complexity, and geography, this position could be a role with management responsibilities for field medical personnel in the region
  • Lead change and encourage a mindset of experimentation and innovation to continually refresh and enhance the customer experience 
  • This position may be accountable for covering more than one healthcare region pending business needs

Qualifications

  • Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.)
  • 10 years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with demonstrable evidence of successfully partnering with customers and achieving shared goals and outcomes
  • Developing and implementing strategy across complex healthcare environments with an ability to influence without authority and mobilize colleagues to action around shared goals
  • Ability to lead complex cross-functional account teams and operating under ambiguity without a set playbook, including aligning teams
  • Strong ability to lead, influence, and work in a matrixed environment regardless of reporting structure
  • Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
  • Excellent understanding of external laws, codes and company policies that apply to the healthcare industry

CMG Operating Principles

● I put the patient first, always.

● I am obsessed with meeting customer needs.

● I act on behalf of the whole company, not just my team.

● I am inclusive.

● I build a culture of trust.

● I have a growth mindset.

● I act with urgency.

● I am accountable.

● I radically simplify and prioritize for impact.

● I follow the science.

● I build our reputation.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

 It is highly preferred the candidate live within the region.  

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

Colorado applicants are not eligible.

#LI-CG2

#LI-Remote

3/4/21 Manufacturing BioProcess Sr. Master Technician (Contractor) Individual contributor Vacaville, California

Contractor position, duration 6 months with possible extensions

Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management.   Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:

Upstream Manufacturing (UM):  Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations; perform seed train operations; perform dispensing of components; handle and aliquot hazardous materials.

Downstream Manufacturing (DM):  Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems; perform dispensing of components; handle and aliquot hazardous materials.

Production Services (PS):  Provide support to Manufacturing to meet production demands.  Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean and Kanban, glassware, parts and equipment; perform weighing and kitting of components; handle and aliquot hazardous materials; Provide quality materials and service to our customers.

Job Responsibilities

Leadership & People Management:

  • Serve as an example and advocate of ingrained quality
  • Champion safety improvements and encourages safe work practices in department
  • Contribute to a LEAN work environment by acting as a change agent and utilizing OE Tools
  • Contribute to the improvement of training material and practices
  • Serve as department representative on cross-functional teams
  • Demonstrate Roche Leadership Competencies within Department and to the site
  • Be able to act as SME to regulatory agencies
  • Lead troubleshooting efforts to resolve complex process issues

Technical:

  • Follow established safety and environmental guidelines and procedures for all work performed. 
    • Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions
    • Fosters safe work practices
  • Operate systems that clean and sterilize tanks and filtration systems. 
  • Prepare materials for the production process.
  • Be able to efficiently navigate the Operator Interface Terminal graphics, and understand the operations as displayed on the screen
  • Exhibit detail oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)
  • Escalate process issues as necessary to ensure resolution of issue
  • Comply with cGMP, SOP and manufacturing documentation.
  • Use automation to perform production and equipment operations.
  • Provide support to Manufacturing to meet production demands.
  • Assemble and prepare equipment for production.
  • Communicate effectively and professionally work in a team environment.
  • Be able to perform all routine operations
  • Train other technicians in group and individual settings
  • Troubleshoot process equipment and systems

Job Requirements

Education:

  • Required: High School Diploma
  • Highly Desirable but not required: BS/BA in Biological Sciences, Physical Sciences, or Engineering or combination of college coursework and related work experience or Biotech certificate from approved program

Knowledge/Skills/Competencies

  • Strong oral and written communication skills.
  • Familiarity of computer-based automation systems
  • Ability to understand and provide input to mechanical operations of the equipment and SOPs associated with that
  • Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.
  • Ability to read and understand engineering documents is desirable
  • Experience in creation and revision of Standard Operating Procedures and Manufacturing Formula is desirable.

Work Environment/Physical Demands/Safety Considerations

  • Must be able work weekends, off-shifts, and overtime as required.
  • No make-up or jewelry can be worn when working in the clean room environment.
  • Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam, water, air and cleaning/sanitizing chemicals systems. 
  • Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift.
  • Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift.
  • Handle and work with hazardous materials and chemicals per OSHA guidelines.
  • Usage of hearing protection and dust masks may be required.
  • Expected to be on feet standing or walking for up to 90% of shift.
  • Travel up to 30 flights of stairs each shift to maneuver within the facility.
  • Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems.
  • Lift up to 40lb(18.2kg) loads multiple times per shift and carry up to 30 lbs.(13.6kg). Team lifting will be used for heavier or awkward lifts/carries up to 20 times per shift.
  • Push or pull materials with up to 50lb-force with full body. Utilize mechanical means or powered industrial trucks for forces beyond the 50lb-force limit up to 10 times per shift.  
  • Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces must be exerted. Forces should not exceed 22 pounds/inch2 (10 kg/cm2).
  • In order to operate powered industrial trucks, employee must pass a DOT Physical which includes: Blood Pressure <140/90, Vision must be at least 20/40 in both eyes with or without corrective lenses, pass color vision and whisper hearing test as well as have a valid Driver’s License
3/4/21 Field Engineering Specialist - CT Individual contributor Connecticut

Territory: Ideal candidate will be located in Western MA and CT

Job Facts:

This is an exciting time to join Roche Support Network! Are you hardworking and a problem solver? Then this is the position for you! As a research-focused healthcare company, Roche discovers, develops and provides innovative diagnostics and therapeutic products and services that deliver significant benefits to patients and healthcare professionals - from early detection and prevention of diseases to diagnostics, treatment and treatment monitoring. We are a successful company that can offer exciting career opportunities. We encourage and support your development in areas of your interest which will prepare you for the next level in your career path. We know that people are responsible for our success, and we value our employees. Our dedication is to build a work environment where feeling valued, respected, and empowered is a daily experience. Roche is an equal opportunity employer.

The Opportunity:

The Roche Support Network group is committed to providing industry-defining support to its customers. As a Field Engineering Specialist, you will have the opportunity to travel and demonstrate your expertise as a technical repair and/or installation specialist for Roche assigned product lines, and provide valued service to your laboratory customers in an assigned territory. The Field Engineering Specialist, in the Roche Support Network, serves as a technical repair specialist to assigned product lines and geographies. We offer an extensive training program, company car, and additional tools you will need to be successful.

The Roche FES also:

  • Provides routine technical support to customers on operational and maintenance aspects of system equipment

  • Performs on-site service, repair and/or installation of company products - This may include any aspect of field support and is not limited to mechanical/system hardware and software, networking/wireless networking

  • Serves as customer contact on routine technical and service related problems

  • Schedules and performs preventative maintenance per department guidelines

  • Supervises customer equipment performance and is able to respond and resolve most routine issues

  • Refers sophisticated problems and issues to higher levels

  • Receives training and delivers service within the normal scope of the position

  • Follows documented practices, policies and procedures in providing repair and installation support

  • Diagnoses mechanical, hardware, software and system failure, using established procedures

  • Resolves most efficient repair/resolution to minimize customer downtime

  • Provides analysis, feedback and recommendations on product failure trends and service ability issues

  • Documents all activity in a manner aligned with company’s quality procedures

  • Is responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions

  • Is responsible for ensuring and maximizing customer satisfaction with Roche equipment and related products

  • Promotes effective, positive, and productive communication among team to ensure and improve happiness of customer base

  • Leads customer accounts at a level that promotes goodwill, confidence and credibility in order to exceed customer expectations in terms of product, service, and support quality

  • Identifies revenue generating and cost saving opportunities, implements the Roche Diagnostics service agreement policy, and seeks out opportunities to market service contracts to existing customers

  • Maintains expenses within departmental guidelines and controls inventory and all company property

Who You Are:

  • High school diploma and 2 years of technical school or equivalent military training or equivalent work experience

  • 5 years of progressive experience repairing or servicing mechanical/system hardware and software, or networking/wireless networking or a Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Chemistry or related field plus 1-2 years of progressive experience repairing or servicing complex mechanical/system hardware and software, or networking/wireless networking

  • Successfully training or certification as defined by RD Services Leadership and policy

  • Advanced knowledge of electronics, electro-mechanical systems, and information technology

  • Ability to serve as an internal technical resource for lower level staff

  • Knowledge of basic chemistry

  • Ability to work after hours, provide weekend and holiday support on a rotated basis within an assigned territory and/or geographic region and be on call 24/7 during rotation

  • Good written/verbal communication, organization and prioritization skill

  • Effective customer service skills, which includes a positive attitude, helpful customer interaction, and maintenance of ongoing customer relationships

  • Ability to travel, including some overnight travel, is required

Colorado applicants not eligible  

#LI-MG1

3/3/21 Technical Development Scientist Individual contributor South San Francisco, California

***Please note this role may be filled at the Associate Scientist or Scientist level***

We are looking for a highly motivated microbiologist to join the Process Virology team in Purification Development within Pharma Technical Development (PTD).   The candidate will play a critical role in enabling microbiology developmental capabilities in close collaboration with PAC-Validation Testing and Cell Therapy departments in PTDU.

Extensive hands-on experience and in-depth knowledge in microbial physiology and testing are required.  Creative thinking, scientific rigor, experience in method development and validation are essential. The selected individual is expected to work independently as well as in a team setting to design and execute experiments and strategies. 

Main responsibilities

  • Provide technical oversight for microbiological method suitability and method validation for IMPs manufactured at CMOs. Review study protocols, reports and test procedures.
  • Oversee design and execution of microbiological testing operations outsourced to CLOs. Author study protocols, manage study logistics, review study results and author reports.
  • Coordinate with stakeholders and manage studies to meet product development timelines.
  • Design and execute the development of new microbial detection methods such as rapid sterility testing to process/product development in PTDU.
  • Work collaboratively with the appropriate functions in PTDU and microbiology SMEs in the Roche network.

Who you are

  • PhD, Bachelor or Master degree in microbiology or equivalent with3-5 years of industrial or clinical experience.
  • Candidates must have a strong background in microbiological tests routinely used for IPC and lot release
  • In depth knowledge in compendia methods (USP, EP, and JP) used for microbial testing
  • Knowledge and experience in novel microbiological methods.
  • Demonstrated trouble-shooting capabilities and problem-solving skills, and hands-on work in lab.
  • High flexibility and strong work ethic.
  • A ‘can-do’ attitude, with the ability to deal with ambiguity, manage complex situations and to “think out of the box” and challenge the status quo
  • Demonstrated ability to coordinate multiple tasks and manage priorities
  • Strong verbal and written communication skills including the ability to present scientific results clearly and concisely
  • A strong desire to work in a collaborative, multi-disciplinary environment;
  • Customer-focused, motivated, detail-oriented, with excellent organizational skills
3/3/21 Ophthalmology Surgical Device Specialist- multiple available territories Individual contributor United States of America

Surgical Device Specialist- Ophthalmology

*Multiple Locations available across the US* See note at the end of job posting

WHO WE ARE

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.   Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

Our team, Ophthalmology Marketing, is all about creating the best experiences for patients, their families, and their care teams. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver ever better health outcomes for patients while lowering overall healthcare costs. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. Come work with a passionate group that loves rising to the challenge and thrives in a fast-paced, ever-changing, and evolving Ophthalmology landscape!

POSITION OVERVIEW

The Surgical Device Specialist (SDS) is integral to successfully delivering the Ophthalmology Marketing Vision, working closely with healthcare providers on the introduction of PDS (Port Delivery System) into the market. The SDS deeply understands the specific needs of retinal surgeons in their therapeutic area to identify and address their clinical and business goals and challenges in support of improved patient experience, optimal surgical outcomes, and improved quality of care.

The SDS is responsible for managing the complexity of launching a surgical device and a new pharmaceutical product within an increasingly complex and dynamic competitive marketplace.  In alignment with the marketing vision and PDS strategic plan, the SDS is accountable for driving on-label clinical demand and delivering on-market surgical device training to retinal surgeons to encourage identification of the right medication for the right patient. This professional embraces innovative approaches and is comfortable in a growing commercial organization.  The individual must be creative and adaptable to unique and changing situations, be a self-starter, goal-oriented, know how to set achievable targets, and motivate internal cross-functional teams as well as field partners. The SDS is empowered to own the business for their territory and to optimize as appropriate; focused on developing effective customer partnerships to improve patient care, deliver excellent surgical procedure training to optimize outcomes, and establishing Genentech as a trusted leader and partner. The SDS will report into a SDS Field Director who will report into the Head of US Ophthalmology Marketing.

KEY RESPONSIBILITIES

Surgical Training Procedure Core Responsibilities:

  • Provide surgeons and clinical staff with technical information regarding the use of PDS prior to, during and/or after surgical procedures; respond to customer queries
  • Apply product proficiency by ensuring customers in assigned territory comprehend technical specifications and on-label use of products
  • Verbally deliver clear and concise instruction on the safe and efficacious use of PDS to customers in and out of the OR setting, including in-services for surgeons and staff
  • Work with physician’s scheduler and OR staff to get PDS cases scheduled and ensure all product/supplies are ready
  • Scrub into PDS surgical procedures on a daily basis
  • Lead surgeons through training sessions, helping them understand the PDS procedure

Business Core Responsibilities:

  • Develop an understanding of each account's culture, competitive pressures, financial priorities, stakeholders and decision makers
  • Through outstanding customer service, maintain a high retention rate of current accounts in territory
  • Conduct quarterly business reviews to exhibit achievement of objectives and goals in all assigned accounts
  • Maintain awareness of competitive trends/marketing practices, and keep management informed on learnings to support building a commercial surgical device capability
  • Drive continuous expansion via a strategic account plan to build adoption and a qualified lead funnel in assigned territory which is tailored to the local market
  • Leverage marketing materials, white papers and evidence through consultative selling
  • Build and maintain strong, lasting relationships in assigned accounts to support continued business
  • Identify opportunities for surgeons to attend sponsored professional training programs, and participate in programs and labs (where appropriate)
  • Research general account context to understand hospital/ASC economics and integrate economic value messages into consultative selling dialog, where appropriate
  • Effectively convert high potential leads and drive training activities
  • Participate in the formulation of national marketing strategies for PDS and serve to orchestrate local tactical execution
  • Liaise with BEMs and FRMs, to assist key targets accounts in maximizing their potential through practice development initiatives and clinical expertise.

KEY CAPABILITIES:

  •  Demonstrates Foundational Capability In The Following:
  • Customer, Product and Market Insights:  Ability to understand, integrate and synthesize insights across customers, competitors, therapeutic or business areas and markets to inform customer-centric business decisions
  • Market Execution: Ability to create, implement and iterate impactful tactics with clear and measurable outcomes to the business and the customer
  • Surgical Device Procedure Training: Proven experience delivering clear and concise instruction on the safe and efficacious use of surgical products to customers in and out of the OR setting, including in-services for surgeons and staff. Effective at compliantly providing surgeons and clinical staff with technical information regarding the use of PDS prior to, during and/or after surgical procedures; respond to customer queries
  • Leadership: Identifying, developing and maximizing effective working relationships with field partners, marketing, and home office personnel to gain alignment on customer needs and optimize business and customer outcomes.

KNOWLEDGE AND SKILLS:

  • Good working knowledge of industry dynamics and trends required combined with strong knowledge and experience in surgical training
  • Able to quickly build confidence in customers despite not having long-term relationships
  • Comfort interacting with surgeons and experience engaging in an operating suite
  • Advanced written and verbal communication skills
  • Independent and innovative thinker who thrives in a consultative selling environment
  • Strong presenter who has the ability to express ideas that build commitment and trust
  • Ability to thrive in an ambiguous environment undergoing transformational change
  • Strong analytical skills via utilization of research and data to shape strategies and tactics
  • Ability to translate strategic direction into an individual action plan and make progress in the face of ambiguity with a growth mindset

EXPERIENCE:

Required:

  • 3+ years in surgical device procedure training
  • Bachelor’s degree or equivalent surgical device industry experience
  • Be proficient in GCP (Good Clinical Practice), Adverse Event reporting and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
  • Maintain a valid driver’s license, all necessary certifications, and vendor credentialing
  • Travel Requirement: within territory (40%), national and conferences (weekends and evenings required)
  • In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening).

Preferred: 

  • 5+ years selling experience in biotech industry/pharmaceutical or biotech field sales strongly preferred
  • Class III Medical Device experience strongly preferred
  • Ophthalmology therapeutic area experience
  • MBA or other related graduate level degree
  • Marketing experience in other relevant industries
  • Alternative Combinations/Other Professional Credentials: Ophthalmic surgery expertise, Designation as Optometrist, Optician or Ophthalmic technician

Genentech Operating Principles:

  • I put the patient first, always
  • I am obsessed with meeting customer needs
  • I act on behalf of the whole company, not just my team
  • I am inclusive
  • I build a culture of trust
  • I have a growth mindset
  • I act with urgency
  • I am accountable
  • I radically simplify and prioritize for impact
  • I follow the science
  • I build our reputation

Notes:

  • This is a remote position; however, the individual must reside within the territory boundaries given extensive travel requirements of the SDS role
  • This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.
  • Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
  • Colorado Applicants: base salary ranges are anticipated to be between $99,000-$115,000

Geographical Locations are as follows (you will be considered for positions closest to where you live unless you note otherwise in your resume):

Seattle; San Francisco; San Jose; Southern CA; Denver/WY; UT/ Western CO; Arizona/New Mexico; Dallas/ Oklahoma; Houston/ Austin; Minnesota/ Iowa/ Kansas; Chicago/ St Louis; Michigan; Indiana/ Ohio; Tennessee/ Kentucky; Alabama/ Georgia; Gulf Coast/ W Florida; Miami/ E Florida; Virginia/ North Carolina/ South Carolina; Washington DC; Baltimore; Pennsylvania/ New Jersey; New York City/ Long Island; Boston/ New England

3/3/21 Pharmacovigilance (PV) Clinical Associate Individual contributor South San Francisco, California

The PV Clinical Associate performs the tactical and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety. The PV Clinical Associate leads clinical review of USDS cases (processed in-house or externally by vendor) and supports the US Drug Safety PV Clinical Manager - Associate in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Associate.

Key Accountabilities:

•Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with

pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures(SOPs)

oReviews, evaluates and verifies potential AE information during Preliminary Assessment (PA) to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via Roche global safety database. Performs seriousness / validity / causality and conducts quality review of all cases (as applicable) based on their medical assessment

oPerforms labelling assessment for AE(s) received using clinical knowledge and conducts follow up for all reported cases (as applicable)

•Responsible for Clinical Review of cases processed in-house and by vendors

oPerforms trend analysis of vendor case processing issues and escalates to vendor and USDS management

oResponsible for developing executive summary on the quality trends observed on a quarterly basis

oResponsible for training internal USDS and/or vendors staff or team in collaboration with SP PV oversight based on trend analysis

oResponsible for ensuring appropriate data correction in the safety database for identified issues or errors

•Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Clinical Associate/Vendor staff via communication module

oAccountable for training internal and external staff members on using communication module

oPerforms daily reconciliation of outgoing communications

•Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable)

•Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners

•Supports PV Clinical Specialists in tasks and projects as needed

•Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)

•Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)

•Acts as single point of contact with key stakeholders for safety related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Drug Safety management

•Responsible for the preparation and development of Drug Safety presentations and participates in the education off or internal /external stakeholders as applicable

•Acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs

•Provide support during audits and inspections

•Collaborates with PV Operations and SP PV Oversight teams as needed

Competencies Identified for Success:

•Demonstrates capability to comprehend medical information

•Demonstrates ownership, initiative and accountability

•Sound decision making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility

•Demonstrates strong, dynamic leadership skills

•Works well independent or within teams and is effective in collaborating with others internally and externally

•Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems and effectively make decisions of moderate complexity and scope e.g. evaluate, interpret and present highly complex data

•Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points

•Ability to flex and thrive in an agile and fast changing environment

•Strong attention-to-detail



Education, Experience, and Other Requirements:

•Health Care Professional degree (Required)

•Minimum 0-2 years of clinical experience (Required)

•Writing experience; science/medical writing (Required)

•Computer proficiency (Required)

•Data entry experience (Preferred)

•Able to travel as per business needs

3/3/21 Global Studies Manager Manager with direct reports South San Francisco, California

At Roche/Genentech Pharma Product Development Operations we are determined to transform drug development and deliver novel medicines with outstanding benefit to patients at lower costs for the society. We want you to join us on this quest and be part of a highly passionate, global and collaborative team who takes pride and energy from challenging the status quo and finding fit for purpose solutions while executing our clinical trials with excellence. Bringing better lives to patients is our core aspiration and is at the heart of each of us while introducing innovation, fostering creativity and being part of high performing teams.

YOUR FOCUS

You will be focused on molecules within one of our exciting therapeutic areas in Oncology or I2ON, having the opportunity to experience our multiple areas over time

YOUR TEAM

You will report to a Global Studies Leader You will be recognized as a leader and work autonomously in a cross functional, global team

WHAT YOU WILL DO

As a Global Studies Manager (GSM) at Roche/Genentech, you will lead or contribute to one or more cross-functional global working groups, expert squads, and global Study Teams, which deliver all operational aspects of one or more studies through all phases and stages. You will:

  • DRIVE OPERATIONAL EXCELLENCE By developing operational plans, creating and managing clinical study budget and overseeing the consistency of operations
  • MANAGE VENDORS AND STAKEHOLDERS By managing relationships with vendors and cross-functional stakeholders. Oversee performance of vendors and third-party providers
  • LEAD AND INFLUENCE By establishing yourself as a leader within the team, being recognized as a thought leader who inspires others to perform at their best and learn from best practices. You’ll be shaping our capabilities and evolving your role overtime
  • MANAGE RISK AND COMPLIANCE By developing site monitoring and risk mitigation strategies and ensuring your team adheres to all appropriate standards, including ICH/GCP and other regulations
  • PLAN DEMAND AND SUPPLY By overseeing the resource management, forecast and maintenance of supplies needed to ensure sites have the necessary supplies to run clinical studies
  • PROVIDE COUNTRY OVERSIGHT By leading feasibility assessments to ensure countries and sites are selected for participation in trials. Provide guidance to country operational reps during trials

HOW YOU WILL DO IT

  • You will succeed as a Global Studies Manager by leading, collaborating, and relaying your expertise to cross-functional partners. You will
  • Apply your good knowledge of drug development process and respective regulations, including ICH and GCP guidelines
  • Apply your organizing and problem-solving skills to plan and run efficient operational aspects of a study
  • Motivate others to deliver against commitments, including leadership of global teams across diverse cultures and time zones, embracing diversity and creating a culture of inclusion to ensure successful collaboration
  • Demonstrate agility and ability to perform in a highly fast-paced, matrix environment where cross-team collaboration is crucial
  • Leverage excellent verbal and written communication skills to motivate your team, negotiate with peers and partners and influence across stakeholders
  • Advocate for what you and your team need to succeed
  • Model Roche’s values in everything you do

WHO YOU ARE

You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, rigorous and entrepreneurial spirit. You…

  • Have a growth mindset and are excited about learning through experience
  • Feel comfortable thinking on your feet and thrive in fast-paced, ambiguous and highly collaborative environments
  • Have a minimum 3 years of relevant experience (clinical trial management is a plus)
  • Hold a university degree or equivalent years of experience, preferred focus in life sciences
  • A self-starter who finds passion in achieving successful outcomes by leading, directing and inspiring peers
  • Want to make a difference and find excitement in innovating practices, products and processes
  • Possess strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines

At Roche/Genentech, we believe our people are Key to our success in bringing novel medicines to patients and we are fully dedicated to being a great place to work and to provide the services, tools and the environment where everybody feels empowered, trusted and is enabled to uncover his/her true potential. Come join us and help build a diverse and inclusive organization where patient centricity and patient access is a priority.

3/3/21 Postdoctoral Fellow - Protein Analytical Chemistry Individual contributor South San Francisco, California

The Position

We are seeking a highly talented and motivated postdoctoral fellow to develop and establish a function-structure based approach to better resolve and sequence chemically modified  and functionally distinct antibody variants to better identify critical quality attributes (CQAs) of antibody drugs and targets for multi-attributes monitoring (MAM) by LC-MS.

 

The selected candidate will develop and apply advanced technologies, including established and new functional affinity chromatography in combination with middle down and other types of LC-MS approaches, for science-based drug development. Potential applications include CQA assessments, function/structure linkage, and identification of targets for MAM by LC-MS. In addition, the candidate will be able drive their own ideas and collaborate across Genentech and Roche Global. This work will include a strong cross-functional collaboration with the multiple other Pharmaceutical Technical Development (PTD), Genentech Early Research and Development (gRED) and Roche Early Research and Development (pRED) departments. 

 

For information about the Postdoctoral Program at Genentech, please go to www.laurenreeser.com/careers/academic-programs/postdocs

Who You Are

The successful candidate will be a recent PhD graduate in Analytical Chemistry, Biochemistry, Chemical Biology, or a related discipline. A strong publication record should provide evidence of productive, independent contributions in science. The applicant must have demonstrated expertise in protein characterization using LC-MS analysis in areas such as native MS, middle down/top down MS, post-translational modifications, and/or bottom-up MS technologies.  Prior experience with bottom up/middle down LC-MS and data analysis with bioinformatic tools is highly desirable. Applied applications of MS with function affinity chromatography is the most relevant skill set, but not a requirement.

Former experience in general analytical protein chemistry, such as protein-protein interaction technologies, protein isolation and purification are advantageous. The successful candidate must be highly self-motivated, capable of working independently, have excellent oral and written communication skills, and enjoy working in a collaborative setting.



 

3/3/21 Senior Scientific Researcher, Functional Genomics-Advanced Screening Technologies Individual contributor South San Francisco, California

We are seeking a Senior Scientific Researcher to contribute to our Translational Genomics effort and help drive functional genomics across the Genentech Research organization. Translational Genomics spans the interface of human genetics, functional genomics, molecular biology, cellular and tissue profiling, disease model engineering, and advanced computational methodology.

She / he will work in a fast-paced and highly collaborative environment to address important questions from our research community. Specifically, she/he will employ the latest functional genomics screening and assay tools to interrogate these questions in close collaboration with the rest of our Translational Genomics Team and Therapeutic Area scientists.

Responsibilities

  • Responsible for designing and performing arrayed or pooled functional genomic screens with multimodality single cell readout.

  • Responsible for developing new functional genomics assays.

  • Collaborate with disease experts across the different therapeutic areas.

  • Contribute to high impact publications in high quality scientific journals and will have the opportunity to present through presentations at key internal and external meetings.

Qualifications

  • The candidate must have a doctorate degree in Molecular Biology, Biochemistry, Genetics, Cancer Biology, Immunology, Neuroscience, or a related discipline. Post-doctoral or equivalent experience desirable.

  • Highly motivated, can lead technology development independently.

  • Must have experience with one or more of the following areas:

  • NGS library preparation especially single cell sequencing technologies or

  • Large scale single cell / bulk CRISPR screens in various settings including in vivo, ex vivo, and cell line systems or

  • Experience of developing novel NGS / microscopy / microfluidic assays.

  • Proficient in bioinformatics including high throughput omics, visualization, and interpretation is highly desirable.

  • Experience in any of the following areas is highly desirable: tissue engineering such as direct cell reprogramming, iPSCs differentiation or organoid culturing.

  • Excellent interpersonal skills with demonstrated ability to work within a team comprised of diverse expertise.

  • Excellent oral and written presentation skills.

#translationalgenomics

#LI-NN1

3/3/21 Scientific Manager, Computational Immunology Manager with direct reports South San Francisco, California

The department of OMNI Bioinformatics is seeking a highly motivated computational scientist to coordinate and manage computational projects within the Immunology department. The successful applicant will lead a team of researchers and engineers to support computational projects across Immunology. 

The successful applicant will work closely with leadership in both the Bioinformatics and Immunology Departments to prioritize and resource broad computational projects, in order to identify new therapeutic hypotheses and advance transformative medicines. The successful applicant will collaborate with Bioinformatics and Immunology Scientists to coordinate, scope, and manage computational projects. The successful applicant will directly oversee and manage a pool of researchers and engineers responsible for performing computational work across the Immunology department. The candidate will also collaborate regularly with computational staff to extend computational and analysis capabilities for novel and emerging technologies. The candidate will lead independent research projects and publication of scientific and/or methodological papers is an important component of this position. 

Qualifications:

  • Postdoctoral training or exceptional PhD experience in bioinformatics, biostatistics, computational biology, software engineering, or a similar field

  • Scientific publication record

  • Previous experience managing collaborative scientific projects

  • Excellent project management and organizational skills

  • Deep understanding of computational approaches for analyzing high-resolution datasets

  • Expertise in a programming language such as R or python, experience with version control systems, and familiarity with high-performance computing environments

  • Excellent communication and data presentation skills, including the ability to explain complex scientific results to a diverse audience

  • Intense curiosity about the biology of disease and eager to contribute to scientific and computational efforts focused on understanding the molecular mechanisms underlying disease etiology

Join our Talent Community. By joining our Talent Community, your resume will be available to our recruitment team, Join today!

Important Information

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the poster.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected].

Genentech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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