What will you be empowered to do?
Sr. Clinical Scientist/Sr. Medical Director
South San Francisco, California, United States
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/.
23andMe has a dynamic interface between target discovery teams and clinical development physicians/ scientists. Clinical development physicians provide medical knowledge and experience to evaluate unmet need in disease to ensure that the target discovery is directed at developing medicines where the most impact can be made. 23andMe has a unique dataset combining genetic information and customer’s phenotypes in those who have consented for research. The Clinical development physician interacts with data collection scientists, biology scientists, statistical geneticists and project managers to help manage all aspects of the process.
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 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 cardiovascular and metabolic indications.
What You’ll Do
- Cross-Functional Team membership – leads a clinical science team. 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 analyses data and information necessary to create the clinical development plans and present them for peer review
- Supports the transition of targets from commit to target validation, commit to target, candidate selection and pre-IND planning, IND filing and Phase 1/2 planning.
- Participates in Phenotypic working group meetings providing medical input to data collection and strategic work to enhance target discovery
- 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 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
What You’ll Bring
- M.D with relevant medical experience in cardiovascular or metabolic or Pharm D with clinical science experience in cardiovascular or metabolic drug development
- BS, MS or PhD in biological or other life sciences fields or MD
- significant industry experience preferred. Significant experience acting as medical monitor and contributing clinical expertise into clinical trial design for multiple Phase I - III studies. Significant experience working in cross-functional teams. Experience authoring scientific / medical publications, internal/external presentations and regulatory submissions. Experience w/IND, BLA and NDA in the U.S. or Europe is preferred
- Expertise in independently designing and providing oversight of early to late-stage clinical trials. Expertise leading large cross-functional groups through clinical development strategy execution. Knowledge of international regulatory guidelines and requirements, such as EMA and MHRA. Knowledge of Phase I - IV drug development is preferred. Direct exposure to and knowledge of steps, processes, methodologies and techniques in building clinical development strategies and plans
- Independently conceives approach to more complex deliverables and consistently delivers timely and high quality work. Identifies and recommends improvements that can carry impact across multiple Research and Development areas and teams. With guidance, can manage CRO deliverables and relationship
Note: Job title will be commensurate with experience and academic credentials.
23andMe, headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company’s mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world’s largest crowdsourced platform for genetic research, with 80 percent of its customers electing to participate. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.
At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at email@example.com. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.Back