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Clinical Development Specialist
South San Francisco, California, United States
Who we are
23andMe, the leading consumer genetics company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team uses this data to discover and develop novel medicines to treat important diseases. The team currently has research programs across several therapeutic areas, including oncology, skin, respiratory and cardiovascular disease.
We are seeking a dynamic, proactive, innovative and experienced clinical scientist to design, implement and oversee the prosecution of clinical development plans for programs in multiple therapeutic areas. You will help provide expertise in clinical trial design to project teams developing large and small molecule therapeutics, lead the development of protocols and associated documents, implement and actively monitor ongoing studies, analyze, report and present ongoing data, participate in regulatory interactions, and author or review relevant sections of CSRs, and IND, NDA and BLA filings. The ideal candidate will show a proactive attitude to identifying and addressing barriers to efficient clinical development, reducing technical / regulatory risk and/or increasing speed to approval through innovative trial designs or the development of new tools such as novel endpoints and biomarkers.
You will work in close partnership across various functions including Drug Discovery, Computational Biology, Biomarker Translation, Clinical Operations, Biometrics, Regulatory/Quality and Development Sciences, as well as with external collaborators. You will bring a deep understanding of the contribution of these functions to a successful drug development program, enabling both robust review and a collaborative approach to emergent issues. You will also contribute to cross-functional teams, department meetings, review committees, and conferences as a scientist first, and as a functional expert on clinical development.
What you’ll do
- Act as a clinical representative and content expert to a number of cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of clinical studies.
- Participate in or lead the development of strategies for evaluating novel biomarkers/diagnostics, endpoints and technologies to facilitate disease area understanding and specific molecule programs
- Be responsible for the preparation of documents and reports for regulatory agencies, including INDs and NDAs/BLAs
- Be responsible for addressing, writing and reviewing regulatory queries and labeling requests to support regulatory dossiers
- Integrate findings and strategies across programs in the organization and more broadly in the field, leveraging up-to-date knowledge towards executing innovative, effective clinical development plans
- Build internal alignment on program strategies, establishing productive collaborations with research scientists
- Ensure compliance with appropriate regulatory guidelines and standards
What you’ll bring
- Pharm.D., Ph.D. or M.P.H., or other clinically relevant degree
- 5+ years of experience working as an integral member of a clinical science or related team in a biotechnology or pharmaceutical company; directly relevant work in academia will also be considered
- Experience working across ≥ 2 therapeutic areas; direct experience in oncology, liver disease and/or neuroscience is highly valued
- Experience interacting with US and/or international health authorities; direct participation in IND and/or NDA/BLA filings is highly valued
- Strong interest in research and the ability to initiate, collaborate and lead teams to address scientific issues
- Exceptional written communication and report-writing skills. Prior experience preparing regulatory submissions and responding to regulatory questions a strong plus.
- Excellent interpersonal communication, organizational and leadership skills with an ability to work both independently and in a team environment
23andMe, Inc. is the leading consumer genetics and research company. Our mission is to help people access, understand and benefit from the human genome. The company was named by MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017”. 23andMe has over 5 million customers worldwide, with ~85 percent of customers consented to participate in research. More information about our Therapeutics team is available at https://therapeutics.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.