Director, DMPK

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, and experience with managing external vendors is essential
• Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem solving
• Proficient in Microsoft Office
• Strategic thinker with a professional demeanor
• Able to navigate an ambiguous environment
• Excellent organization skills with a drive for results
• Action oriented with a self-starter attitude
• Excellent written and verbal communication skills