The Position

The Early Clinical Development (ECD) Oncology group at Genentech is seeking a talented Senior/Principal Clinical Scientist who is passionate about translating preclinical discoveries into the next generation of cancer therapies in a highly collaborative team environment.

The role will involve clinical trial development with novel anti-cancer agents within the dynamic and broad Genentech portfolio, which includes antibody and small molecule targeted therapies, immune cell engagers, cytokines, vaccines, and cellular therapy. These programs include first-in-human studies through proof of concept.

The Senior Clinical Scientist/Principal Clinical Scientist participates in development of clinical strategies for assigned molecule(s)/indication(s) and is responsible for the effective and efficient execution of the Clinical Development Plan (CDP) for one or more molecules. Senior Clinical Scientists/Principal Clinical Scientists are expected to perform their responsibilities independently, have core knowledge of the Clinical Science function to enable increased participation in department level initiatives, and may contribute to complex projects with supervision. Senior Clinical Scientists may assume leadership in the responsibilities required for clinical trial planning and study execution, and are capable of leading complex, high visibility projects. Principal Clinical Scientists may oversee or be the manager for more junior level clinical scientists.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Contributes as a standing member of the Clinical Science Sub-Team (CST), and may represent CS on other relevant sub-teams. Presents and leads discussions relating to clinical data or protocol execution. Helps cross-functional team members synthesize/contextualize clinical data to facilitate discussion and decision making. May independently lead working groups and/or sub team initiatives in support of protocol, disease area, or CDP.
• Represents Clinical Science (CS) on Execution Team(s) of assigned molecule(s)/indication(s), and ensures cross-functional integration, coordination and alignment in protocol development and execution decisions and documentation to enable effective and efficient CDP execution. Trains other study team members (internal and/or external personnel) on study protocol
• Contributes to CDP and development of long-range strategy for assigned programs
• Drives authoring, review and team decisions required to develop study protocols, ICFs, and study start-up documents requiring clinical expertise (eg, development/updating of CRFs, monitoring plans, study registry and disclosure etc.), including amendments.
• Conducts medical data review. Collaborates with the Visual Analytics Manager to tailor clinical and safety data required for ongoing medical data review.
• Processes and conducts regular review and analysis of protocol deviations.
• Primary POC for protocol-related inquiries from internal colleagues and external sites. Liaises with Medical Monitor, CST Lead, and other CS team members to address inquiries and drive protocol-level decisions and deliverables.
• May author, in collaboration with relevant team members and/or support functions, clinical sections of regulatory documents, or responses to healthy authority (HA) or ethics committee inquiries.
• Contributes to publications for peer-reviewed journals and/or scientific abstracts for submission to national and international scientific conferences.
• Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.
• Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
• Assists with portfolio enabling work, if requested.
• May assist with clinical evaluation for due diligence activities for in-licensing and development opportunities, if requested.
• May mentor and/or train new Clinical Scientists, Interns, or Rotation candidates.

• Supports or leads business and process improvement goals and initiatives.
• Supports or leads the development/maintenance of CS resources and procedural documents/SOPs

QUALIFICATIONS & EXPERIENCE:

Senior Clinical Scientist: Advanced clinical/science degree preferred (PharmD, PhD, MSN, MPH, etc.), generally 8 or more years pharma/biotech industry experience or demonstrates relevant equivalent clinical or laboratory research experience, generally at least 6 years of experience with clinical trials, generally 2 or more years of experience in same or similar therapeutic area is preferred. Has experience working in complex matrixed setting(s). Experience with cross-functional authoring full clinical trial protocols and/or study results and conclusions. Experience publishing clinical trial results in peer-reviewed journals. Extensive knowledge of clinical research & successfully worked across Phase I – II drug development projects. Has successfully executed a Phase I or II program. Has considerable Investigational New Drug Application (IND) filing experience.

Principal Clinical Scientist: Advanced clinical/science degree preferred (PharmD, PhD, MSN, MPH, etc.), generally 10 or more years pharma/biotech industry experience or demonstrates relevant equivalent clinical or laboratory research experience, generally at least 8 years of experience with clinical trials, generally 4 or more years of experience in same or similar therapeutic area is preferred. Has experience working in complex matrixed setting(s). Experience with cross-functional authoring full clinical trial protocols and/or study results and conclusions. Experience publishing clinical trial results in peer-reviewed journals. Extensive knowledge of clinical research & successfully worked across Phase I – II drug development projects. Has successfully executed a Phase I or II program. Has considerable Investigational New Drug Application (IND) filing experience. Is regarded as a subject matter expert in clinical science development. Previous people management experience is preferred.

Compensation range:

Senior Clinical Scientist: The expected salary range for this position based on the primary location of California is $157,600 and $292,600 of hiring range.

Principal Clinical Scientist: The expected salary range for this position based on the primary location of California is $179,900 and $334,100 of hiring range.

Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits

NOTE: All qualified candidates are encouraged to apply and will be considered. Our talent development strategy and processes have, however, pre-identified a potential candidate for this position.

#LI-RB1

Relocation benefits are available for this job posting.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.