What will you be empowered to do?
Group Head, Development Sciences
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/.
We are seeking an exemplary and experienced leader to join our Therapeutics Development leadership team, lead and contribute to innovations in genetics-based drug development, and provide direction and management to our Development Sciences function, including preclinical and clinical pharmacology, bioanalytics, and nonclinical safety functions, and support the Therapeutics pipeline. They will consider and propose strategies to be implemented to improve the speed and success of drug development. They will provide mentorship, career development, and subject matter expertise, as appropriate, to Development Sciences function members, to project teams for developing large and small molecule therapeutics, and provide leadership for sections of IND filings that rely on PK and toxicology data. They will work with the Head of Therapeutics Development to create a hiring plan appropriate for the stage of the portofolio to recruit and build the Development Sciences function. They will be working in close partnership across various functions including Drug Discovery, Computational Biology, Biomarker Translation and Therapeutics Development, as well as with other internal and external collaborators.
What You’ll Do
- Provide scientific leadership within Therapeutics Development, for internal and collaborative project teams and governance meetings, and GLP compliance and non-clinical safety-related activities ● Lead early development programs, including cross-functional teams or teams focusing on new technologies or organizational infrastructure within Therapeutics or across the company, for example to improve data collection and data useability
- Partner with Drug Discovery, Antibody and Protein Engineering, Computational Biology and project team leaders for research stage programs for evaluation of pre-IND project planning and identification of resources to enable pharmacokinetics and safety assessment of lead, tool and/or surrogate therapeutic molecules
- Be accountable for the design and interpretation of in vitro and in vivo ADME and PKPD studies that are necessary to understand the pharmacology of drug candidates in animals and predict their behavior in humans
- Oversee and direct Toxicology/Pathology outsourced activities during late stage research and early stage development on toxicology investigations including planning for IND-enabling activities; develop hiring plan for in-house resources when appropriate for the portfolio
- Be accountable for and delegate responsibility for the preparation of appropriate sections of preclinical and clinical documents and reports for regulatory agencies, including briefing packages, INDs, CTAs, and NDAs/BLAs
- Identify, recruit and hire preclinical and clinical PK, bioanalytics, toxicology and tox-pathology scientists in coordination with the Therapeutics Development Leadership Team as appropriate to the staffing requirements for the project needs
- Identify and engage appropriate consultants and/or contractors as needed
- Manage internal teams and resources at CROs to ensure appropriate and timely design, initiation, execution and reporting of preclinical and clinical supportive IND studies
- Ensure compliance with appropriate regulatory guidelines and GLP standards
- Maintain compliance with all company policies and procedures
- Perform other related duties as assigned
What You’ll Bring
- Ph.D. or equivalent experience in relevant fields for therapeutics development
- 10+ years of experience in large and/or small molecule drug development in at least one of the Development Sciences functional areas, with demonstration of broader experience across Development Sciences areas in functional interactions
- Substantial experience interacting with US and international health authorities, including direct participation in IND and/or NDA/BLA/MAA filing(s)
- Management and/or experience with outsourced CRO deliverables for bioanalytics, pharmacokinetics, and/or IND-enabling toxicology studies
- 3+ years of management experience with a strong management philosophy that emphasizes high collaboration, productivity, retention, and career development of direct reports and others within the organization
- Strong scientific interest in biological and genetics mechanisms and the ability to initiate, collaborate and lead teams to address scientific issues
- Exceptional written and oral communication skills
- Excellent interpersonal communication, organizational and leadership skills with an ability to work both independently and in a team environment
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