We are seeking a highly motivated and skilled PK scientist to join our dynamic and growing Translational Sciences Team. The successful candidate will act as a PK lead for discovery and early development programs, providing PK/PD and mechanistic modeling insights by integrating ADME and PK/PD data to drive decision making from drug candidate selection to clinical development.
Requirements
- Serve as the PK lead on multidisciplinary teams, partnering with chemistry, platform biology, computational biology, clinical, regulatory, and CMC to advance discovery and early development programs.
- Apply modeling and simulation approaches (PK/PD, mechanistic, PBPK, QSP) to enable nonclinical to clinical translation, guide dose selection, and inform clinical design.
- Design and oversee ADME and PKPD studies, both internally and with CROs, to support drug candidate selection and regulatory submissions.
- Conduct NCA to calculate PK and TK parameters in compliance with GLP and applicable regulatory guidelines to support IND and other regulatory submissions.
- Prepare high-quality study summaries, technical reports, and input for regulatory documents (e.g. IND, IB, BB, etc)
- Integrate DMPK and pharmacology data to build quantitative frameworks to inform structure-activity relationships, target validation, and molecule design.
- Contribute to program strategy by identifying key risks with quantitative understanding.
- Stay current with emerging trends in translational modeling and predictive ADME to help implement innovative tools and best practices.
Benefits
- Comprehensive and competitive benefits package
- 401(k) with competitive company match
- Medical, dental, vision, life insurance
- Health and dependent care FSA accounts
- HSA/HRA accounts with company contributions