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Scientist / Sr. Scientist, Preclinical Pharmacokinetics and Clinical Pharmacology
South San Francisco, California, United States
Who we are
23andMe's Therapeutics team 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 or Senior Scientist with an expertise in Preclinical Pharmacokinetics (PK) for large molecule therapeutics and/or Clinical Pharmacology (ClinPharm) for small or large molecule therapeutics, to provide scientific leadership and hands-on support to our project teams from target validation to IND filing to clinical development. In this role, you will be an initial member of our Preclinical Pharmacokinetics and Clinical Pharmacology group and have the opportunity to influence and make a substantial impact on our programs across multiple disease areas.
We welcome pharmacokineticists with extensive experience in the large molecule preclinical space who are motivated to expand their professional horizon to clinical pharmacology. We equally welcome clinical pharmacologists and/or PK/PD modeling experts who have a passion for biology and are interested in making an impact throughout the entire drug development process. This role will report directly to the Director of Preclinical Development and Clinical Pharmacology.
What you’ll do
- Collaborate with Antibody Engineering and project teams during the research stages concerning pharmacokinetics and immunogenicity of tool and/or surrogate therapeutic molecules
- Collaborate 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 the toxicology investigations, including study protocol, execution and reporting
- Collaborate closely with bioanalytical scientists to provide accurate interpretation of the 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, the First-in-Human (FIH) dose rationale, the clinical pharmacology aspect of the clinical development plan
- Help identify and hire 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. in Pharmaceutical Sciences, Pharmacology, Biomedical or Biochemical Engineering or related discipline
- 6+ years of preclinical pharmacokinetics experience in large molecule drug development and/or clinical pharmacology in small or large molecule drug development
- PK/PD modeling and simulation hands-on capability a strong plus
- 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. Prior experience preparing regulatory submissions a strong plus
- Experience interacting with US and/or international health authorities; direct participation in IND and/or BLA filing is a 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://mediacenter.23andme.com/therapeutics/.
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