Position Summary
Senior Director, DMPK (Drug Metabolism and Pharmacokinetics). Provide scientific leadership in DMPK/ADME across discovery and development, partnering cross-functionally to advance programs from compound screening through IND- and NDA-enabling activities and regulatory submissions.
Essential Job Functions and Responsibilities
- Provide strategic leadership and oversight for DMPK within Discovery.
- Lead development and execution of DMPK strategies for candidate evaluation; expand/optimize training, methodologies, and equipment.
- Serve as DMPK representative on multifunctional discovery and early development teams.
- Define lead candidate characteristics and testing strategies; design, conduct, and report preclinical studies.
- Collaborate with in vitro/in vivo Pharmacology and Toxicology; guide lead optimization, PK/PD, and human dose projections.
- Oversee and contribute to preclinical PK sections of regulatory documents (INDs, NDAs, briefing books, Investigator Brochures).
- Drive team culture of continuous improvement, accountability, professional growth, and inclusion.
- Recommend and lead innovative technologies/approaches.
- Act as subject matter expert; educate cross-functional teams on DMPK principles.
- Identify need for clinical drug interaction studies; support regulatory query responses.
- Recruit scientists and build DMPK teams supporting portfolio advancement.
Required Qualifications
- PhD (relevant discipline) + 13+ years in pharma/life sciences (BS/MS requires 15+ years).
- 10+ years supervisory experience.
- Excellent verbal/written/interpersonal communication.
- Prior small/mid-sized company experience desired.
- Strong problem-solving, risk judgment, cross-functional drug discovery/development understanding, leadership/management, and negotiation skills.