Join our gene pool.
Scientist / Sr. Scientist, 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 accomplished Scientist to advise and provide hands-on support to our project teams from preclinical through clinical development. You will bring expertise in preclinical pharmacokinetics, including distribution and metabolism (DMPK) as appropriate, to project teams for developing large and small molecule therapeutics, and lead PK portions for IND filings. Qualified individuals may continue to lead clinical pharmacology for programs entering the clinic, to support programs through all clinical development stages.
What you’ll do
- Partner with Antibody and Protein Engineering and project team leaders for research stage programs to evaluate pharmacokinetics and immunogenicity of lead, tool and/or surrogate therapeutic molecules
- Work closely with and/or lead the project team during the early development stage with a special emphasis on candidate molecule selection, interspecies PK projection and exposure-effect relationship (i.e., PK-PD modeling and simulation)
- Collaborate with toxicologists during late stage research and early stage development on toxicology and toxicokinetic (TK) investigations; responsible for all TK and immunogenicity aspects of toxicology investigations, including study protocol, execution and reporting
- Collaborate closely with bioanalytical scientists to provide accurate interpretation of PK, TK, and immunogenicity data
- Responsible for all preclinical PK and clinical pharmacology aspects of an IND filing, including but not limited to: the preclinical PK and TK reports, sections of the Preclinical Pharmacology Overview
- Collaborate with the project clinician to establish the First-in-Human (FIH) dose rationale, the clinical pharmacology aspect of the clinical development plan
- 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
- 3+ years of preclinical pharmacokinetics experience in large molecule drug development
- PK/PD modeling and simulation hands-on capability are strong pluses
- Deep understanding of bioanalytical deliverables and limitations
- Strong interest in research and the ability to initiate, collaborate and lead teams to address scientific issues
- Exceptional written communication and report-writing skills, with prior experience preparing regulatory submissions a strong plus
- Experience interacting with US and/or international health authorities; direct participation in IND and/or NDA/BLA filing is a plus
- Excellent interpersonal communication, organizational and leadership skills with an ability to work both independently and in a team environment
Note: Job title will be commensurate to prior experience and academic credentials.
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 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