Join our gene pool.
Director, Preclinical Pharmacokinetics and Clinical Pharmacology
South San Francisco, California, United States
Who we are
23andMe Therapeutics is committed to discovering and developing new therapies that can offer significant benefits for patients. This dedicated research and development group identifies novel targets using 23andMe's genetic database, generates lead compounds for these targets and performs preclinical research to advance programs for clinical development. The team currently has research programs across several therapeutic areas, including oncology, skin, respiratory and cardiovascular disease.
We are seeking an exemplary and experienced leader to provide direction and management to our preclinical and clinical pharmacology function. You will provide expertise in preclinical pharmacokinetics, including distribution and metabolism (DMPK) as appropriate, to project teams for developing large and small molecule therapeutics, provide leadership for sections of IND filings that rely on PK data, and recruit and provide guidance to preclinical PK scientist(s) and clinical pharmacologists as appropriate for the stage of the portfolio. You will be responsible for guiding the investigation of pharmacokinetics, biodistribution, and pharmacokinetic-pharmacodynamic (PKPD) relationships of novel therapeutics in preclinical models to identify optimal lead candidates for further development, and ensuring the translation of preclinical PKPD information to patients for appropriate dose/regimen decisions using state-of-the-art experimental and quantitative approaches. You will also partner across various functions including Drug Discovery, Computational Biology, Biomarker Translation and Therapeutics Development, as well as with external collaborators. You will contribute to cross-functional teams, department meetings, review committees, and conferences as a scientist first, and as a functional expert on preclinical PK and clinical pharmacology.
What you’ll do
- Be responsible for the design, conduct, analysis 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
- Partner with Antibody and Protein Engineering and project team leaders for research stage programs for evaluation of pharmacokinetics and immunogenicity of lead, tool and/or surrogate therapeutic molecules
- Collaborate with Toxicology/Pathology during late stage research and early stage development on toxicology and toxicokinetic (TK) investigational plans and reporting, including all TK and immunogenicity aspects of toxicology investigations
- Provide clinical pharmacology leadership including pre-clinical evaluation of lead compounds to satisfy regulatory requirements, contributing to clinical development plans, and provide input to clinical protocol development and protocol and clinical report writing and reporting
- 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
- Provide scientific leadership within Therapeutics Development, for internal and collaborative project teams and governance meetings, and compliance and 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
- Identify, recruit and hire preclinical and clinical PK scientists in coordination with the Therapeutics Leadership Team, as appropriate, to the staffing requirements for the project needs
- Coach, mentor and manage team members and enable their career development and growth
- 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 PK and TK studies
- Ensure compliance with appropriate regulatory guidelines and standards
What you’ll bring
- Ph.D. or equivalent experience in pharmaceutical sciences, pharmacology, or related discipline
- 6+ years of preclinical pharmacokinetics and clinical pharmacology industry experience in large and small molecule drug development
- PK/PD modeling and simulation capability
- Prior experience managing clinical bioanalytical deliverables through outsourced mechanisms
- Experience interacting with US and/or international health authorities, including direct participation in IND and/or NDA/BLA filing
- Strong interest in research and the ability to initiate, collaborate and lead teams to address scientific issues
- Exceptional written communication and report-writing skills. Experience preparing regulatory submissions a strong plus
- Strong team player with excellent interpersonal communication skills
- Ability to work independently, prioritize and multi-task while maintaining a positive and collaborative attitude
- Experience hiring, managing and developing employees, with varying levels of experience, for performance and scientific growth
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 ~80 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 firstname.lastname@example.org. 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