Position Summary:
Reporting to the VP, Non Clinical Development, the Director, DMPK will lead DMPK and translational pharmacology, collaborating across disciplines to optimize candidate selection, clinical translation, and regulatory success.
Responsibilities:
- Lead DMPK and translational pharmacology strategy across the pipeline (lead optimization through IND-enabling studies and clinical development).
- Develop integrated DMPK/translational strategies to optimize ADME, exposure, tissue distribution, PK/PD relationships, and human dose prediction.
- Design, oversee, and interpret in vitro/in vivo DMPK, ADME, metabolite identification, and bioanalytical studies.
- Partner with Medicinal Chemistry, Discovery Biology, Biomarkers, Toxicology, Clinical Pharmacology, and Clinical Development to integrate DMPK data into program strategy.
- Design/direct/interpret quantitative PK/PD, exposure-response, and PBPK/population-PK modeling to drive mechanism-based dose selection.
- Provide scientific leadership for first-in-human dose projections, clinical pharmacology strategy, and translational plans.
- Identify and address DMPK risks (DDI potential, metabolite characterization, formulation, species translation).
- Select/manage external CROs and partners; ensure quality, timeliness, and regulatory compliance.
- Author/review regulatory submission sections (INDs, CTAs, Investigatorβs Brochures) and support global regulatory interactions.
- Build DMPK capabilities/standards and communicate strategy and recommendations; mentor talent.
Required:
- Ph.D. in Pharmacokinetics/Pharmaceutical Sciences/Pharmacology/Drug Metabolism (or related).
- 12+ years post-Ph.D. biotech/pharma experience advancing small molecules from discovery through early clinical development.
- Proven DMPK strategy leadership (candidate selection, IND-enabling, first-in-human).
- Experience supporting IND/CTA/IB regulatory submissions.
- DMPK representative on multidisciplinary teams; selected/managing CROs/collaborators; mentoring/technical leadership.
Preferred:
- PBPK and/or population PK experience.
- Experience in age/metabolic/obesity/cardiometabolic or chronic diseases.
- Building DMPK capabilities in a growing biotech; people management (plus).