The Director of Clinical Pharmacology and Drug Metabolism and Pharmacokinetics (DMPK) is responsible for overseeing internal and external activities associated with understanding the absorption, distribution, metabolism and excretion properties of multiple drug candidates in preclinical and clinical development. The person will play an active role on cross-functional program teams -- this includes planning development strategies and interpreting data, as well as making hands-on contributions while managing vendors and internal staff. S/he will also be responsible for writing or supervising the DMPK and clinical pharmacology sections for IND/DNA/CTA/MAA submissions.
Prepare strategic and scientifically sophisticated DMPK and clinical pharmacology drug development strategies that meet regulatory requirements and program goals.
Serve as a primary source of scientific expertise for the design, analysis, reporting, and presentation of pharmacokinetic and pharmacodynamic modeling and simulation data.
Establish Clinical Pharmacology long-term goals, establish plan of action for achievement of goals and effect plan of action.
Manage clinical pharmacology staff of 1 direct report and 1-4 indirect reports.
Manage CROs and academic sites in the conduct of in vitro ADME, DMPK and clinical pharmacology studies.
Oversee pharmacokinetic analysis, interpretation and reporting of exposure data from preclinical pharmacokinetic and safety studies, clinical pharmacology studies and clinical trials.
Author/direct high quality regulatory documents including INDs, CTAs and NDA filings.
Maintain current awareness in areas of expertise, prepares abstracts and manuscripts for scientific publications/presentations.
Other duties as required.
REQUIREMENTS / QUALIFICATIONS:
PhD in pharmaceutical sciences, DMPK or related disciplines with thorough knowledge of clinical pharmacology, absorption, distribution, drug metabolism, pharmacokinetics and PK/PD modeling.
Minimum 5+ years of pharmaceutical industry experience including clinical pharmacology studies, DMPK, PK/PD modeling, drug development, protocol/IB preparation support.
Expertise in modeling and simulation, population PK analysis and PK/PD.
Excellent leadership, project management skills and experience with managing external vendors and managing direct reports is essential.
Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem solving.