Position Summary

The Director, Drug Metabolism and Pharmacokinetics (DMPK) will be responsible for overseeing internal and external activities associated with characterizing the preclinical ADME/PK and clinical PK/clinical pharmacology aspects of all programs in preclinical and clinical development in the corporate portfolio.   This position will also help with stage-appropriate diligence evaluations of external opportunities.   The Director 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.   The position will also be responsible for the DMPK and clinical pharmacology sections for IND/NDA (or BLA)/CTA/MAA submissions.   Given the integrated aspect of development, the role will interface closely with various other functions, in particular with bioanalysis, and ensure timely cross-functional information sharing of key DMPK and clinical pharmacology aspects of the program.

Essential Duties and responsibilities

Responsible for the design, analysis, interpretation, and reporting of preclinical, clinical DMPK and clinical pharmacology data generated at external vendors and academic sites

Serve as a primary source of scientific expertise for the design, analysis, reporting and presentation of pharmacokinetic and pharmacodynamic modeling and simulation data

Provide DMPK guidance for hit to lead and lead optimization in discovery programs.

Support tox studies by guiding BA method development and validation as well as TK analysis.

Prepare strategic and scientifically sophisticated DMPK and clinical pharmacology drug development strategies that meet regulatory requirements and program goals

Participate in the management of CROs and academic sites in the conduct of in vitro/in vivo ADME, DMPK and clinical pharmacology studies

Design and oversee clinical food effects, drug-drug interaction, bioequivalence and population PK/PD and tissue distribution / mass balance studies

Perform pharmacokinetic analysis, interpretation and reporting of exposure data from preclinical pharmacokinetic and safety studies, clinical pharmacology studies and clinical trials

Manage preclinical and clinical bioanalysis vendors along with review and interpretation of bioanalytical data and reports

Provide pharmacokinetic and pharmacodynamic modeling support to both preclinical and clinical project teams

Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments

Support DMPK components of preclinical and clinical study protocol designs, preclinical and clinical study reports, and investigator brochures

Prepare protocols, timelines and budgets for healthy volunteer and special population clinical pharmacology studies, monitoring studies and critically reviewing study results and reports

Prepare verbal and written summaries for internal discussions and for regulatory submissions, anticipating and resolving preclinical/clinical DMPK and clinical pharmacology issues that arise during product development

Author high quality regulatory documents including INDs, CTAs and NDA filings

Maintains current awareness in area of expertise, prepares abstracts and manuscripts for scientific publications/presentations

Other duties as assigned

Core Competencies, Knowledge and Skill Requirements

Ph.D. in pharmaceutical sciences, DMPK or related disciplines with thorough knowledge of clinical pharmacology, absorption, distribution, drug metabolism, pharmacokinetics, and PK/PD modeling

10+ years of pharmaceutical industry experience including clinical pharmacology studies, DMPK, PK/PD modeling, drug development, protocol/IB preparation support, regulatory interactions and IND/NDA submissions

Leadership, project management skills