Director of DMPK and Pharmacokinetics

Job Summary

A company is looking for a Director, DMPK - Pharmacokinetics & Clinical Pharmacology.

Key Responsibilities

• Drive DMPK strategy for Discovery and Development phases and represent the DMPK function to project management and leadership teams
• Coordinate and interpret CRO-based ADME evaluations of novel RNA therapeutics and lead an internal lab for metabolism evaluation
• Provide expert advice on IND enabling ADME and PK studies, author regulatory submission sections, and manage CROs for DMPK study execution

Required Qualifications

• Ph.D. in relevant biomedical research with 12+ years of DMPK experience in pharmaceutical drug discovery and development
• Strong track record of publications and authoring submission documents addressing regulatory questions
• Proven ability to drive drug discovery projects from early development through candidate selection and IND
• In-depth expertise in drug metabolism and bioanalysis, especially with ASO, siRNA, and RNA therapeutics
• Experience with external vendor management such as CROs and a solid grasp of ICH regulatory guidance documents relevant to DMPK activities