What will you be empowered to do?
Associate/Sr. Associate Translational Scientist, Pharmacokinetics
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 outstanding pharmacokinetic (PK) scientist to advise and provide hands-on support to our preclinical project teams. They will provide project team expertise in preclinical pharmacokinetics, lead DMPK strategy and execution for nonclinical programs, and author PK portions in support of regulatory submissions, including investigational new drug (IND) filings. Successful candidates will have experience independently planning, executing, and interpreting preclinical pharmacokinetic studies, authoring study reports, and contributing to regulatory document submissions. 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
- Lead DMPK strategy and execution for nonclinical programs of primarily large molecule therapeutics, with a special emphasis on candidate selection, interspecies PK projection, and exposure-effect relationships (i.e., PKPD modeling and simulation)
- Represent DMPK on cross functional project teams and be accountable for the overall DMPK project plans
- Lead cross-functional nonclinical pharmacokinetic study teams
- Design, conduct, analyze, and interpret preclinical pharmacokinetics studies of lead, tool, and/or surrogate therapeutic molecules in line with project team goals and priorities
- Collaborate with strategic sourcing colleagues to manage outsourced studies/activities in accordance with outsourced strategies, including vendor selection, development of services agreements and scopes of work, budgets, timelines and performance management..
- Collaborate with the toxicology study team on toxicology and toxicokinetic (TK) investigations and contribute to all TK and immunogenicity aspects of toxicology investigations, including study protocol, execution, and reporting
- Conduct noncompartmental and compartmental pharmacokinetic analyses using Phoenix WinNonlin
- Project dose-response relationships based on data in preclinical animal models and/or in vitro human pharmacology data
- Routinely present DMPK study design, results, and strategy to project teams
- Author PK and TK reports and PK sections in support of regulatory submissions
- Ensure compliance and keep up-to-date with appropriate regulatory guidelines and standards
- Maintain compliance with all company policies and procedures
- Perform other related duties as assigned
What You’ll Bring
- PhD in life sciences, or commensurate experience in the pharma/biotech setting
- Hands-on experience with large molecule preclinical and/or translational pharmacokinetics
- Hands-on experience with PK software, such as WinNonlin, Berkeley Madonna, NONMEM, R, etc., and GraphPad PRISM
- Proven ability to manage CROs or other external vendor deliverables and relationships
- Demonstrated understanding of large molecule PK concepts, like target-mediated drug disposition and half-life extension
- Demonstrated understanding of routine large molecule bioanalytical techniques
- Understanding of the application of statistics to interpret and report pharmacokinetic data
- Understanding of regulatory requirements for study types
- Proven effectiveness to deliver data for filings and/or publications
- Ability to think strategically and advise project teams on nonclinical development
- Advanced communication skills to convey complex information to both specialist and non-specialist audiences. Consistent communication in a manner that builds trust and enhances alignment with others.
- Routinely goes out of their way to help others. Takes initiative to support the whole team. Appreciates and leverages diversity across the team. Highly regarded as a trusted advisor to cross-functional partners and stakeholders.
- Proactive and highly self-motivated with strong analytical and troubleshooting skills.
- Industry experience (1-3 years) with the development of antibody therapeutics
- IND filing experience
Note: Job title will be commensurate with experience and academic credentials
23andMe, Inc. is the leading consumer genetics and research company. Founded in 2006, the mission of the company is to help people access, understand, and benefit from the human genome. The company was named by Glassdoor as one of the Best Places to Work in 2019, 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 millions of customers worldwide, with more than 80 percent of customers consented to participate in research. 23andMe, Inc. is located in Sunnyvale, CA. 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 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