Sr. Clinical Scientist

Who We Are

23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.

This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.

The clinical scientist / medical director is responsible for developing and executing the development (Phase I – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Senior Clinical Scientist/ Senior Medical Director leads development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution for the agreed molecule(s)/indication(s). Senior Clinical Scientist/ Senior Medical Directors may oversee contractors/consultants and have direct reports. Senior Clinical Scientist/ Senior Medical Directors are expected to perform their responsibilities independently and demonstrate mastery of the core Medical Director role and effectively lead multiple projects; including participating in health authority (HA) interactions with little to no supervision from their managers.  

This job will have a particular focus for oncology indications. 

What You'll Do

• Cross-Functional Team membership – leads clinical science activities for assigned molecule/program. Represents development in cross functional teams and ensures cross-functional integration, coordination and alignment to enable effective and efficient CDP execution.
• Clinical development planning – stays abreast of internal and external developments, trends and other dynamics relevant to the work of clinical assessment and leadership of medicine development.
• Gathers and analyzes data and information necessary to create the clinical development plans and presents them for peer review. Updates clinical development plan based on emerging clinical data and therapeutic area advances and trends.
• Supports the transition of targets to candidate selection and pre-IND planning, IND filing and Phase 1/2 planning and execution. 
• Monitors clinical trials and leads scientific and medical aspects of clinical studies in close collaboration with clinical operations. Responsible for clinical science input for key study-related documents including protocols, amendments, study plans, etc and routine clinical data review in partnership with data management team members to ensure data is of high quality.
• Partners closely with pharmacovigilance team members on safety monitoring and provides clinical science contribution to key documents including the DSUR, Investigator’s Brochure, etc. Prepares content and leads routine safety review committee meetings for clinical studies.
• Leads investigator and KOL engagement activities for programs/studies, including leading investigator meetings, scientific advisory board meetings, etc as appropriate. 
• Guides publication strategy and authors scientific publications as appropriate for the strategic information dissemination for the clinical program.
• Can act as Clinical Development lead or co-lead to one or more projects and teams
• Highly regarded as a trusted advisor to cross-functional partners and stakeholders
• Operates w/ considerable independence and autonomy on most assignments. Serves as clinical SME on projects and can interpret and present complex data w/ minimal to no guidance.
• Uses advanced communication skills to convey complex information to both specialist and non-specialist audiences. Consistently communicates in a manner that builds trust and enhances alignment w/ others.
• Is able to deviate from standard Clinical Development processes and techniques when needed. Routinely participates in departmental and cross-functional strategic planning.  Routinely shares best practices and lessons learned to benefit others on the team. Demonstrates ability to think strategically and routinely offers ideas to improve Clinical Development or team outcomes and ways of working.
• Maintains compliance with all company policies and procedures.
• Performs other related duties as assigned.