POSITION OBJECTIVE: 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. Will be responsible for writing or supervising the DMPK and clinical pharmacology sections for IND/DNA/CTA/MAA submissions.
Essential Job Functions/Responsibilities
- 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 1direct 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.
Required Education & 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.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.