Executive Director, Development Drug Metabolism and Pharmacokinetics (DMPK)

We are a recruiting company EasyHiring looking for candidates for the position of Executive Director, Development Drug Metabolism and Pharmacokinetics (DMPK) in South Bound Brook, NJ to work in Princeton, NJ or Summit, NJ for our partners.

Job Description

The Executive Director, Development Drug Metabolism and Pharmacokinetics (DMPK) oversees the research and regulatory activities within the Development DMPK team. The role encompasses scientific and administrative leadership of the entire development portfolio, including all drug modalities, from pre-IND status to regulatory approval. The successful candidate will be responsible for representing the team at internal governance meetings, advising on the best approaches for regulatory reviews and program progression, and ensuring appropriate compliance with guidelines across all health authorities for all matters relating to Development DMPK. The successful candidate will report to the head of Pharmaceutical Candidate Optimization (PCO) and interface with scientists focused on Discovery efforts, collaborate with colleagues in Clinical Pharmacology and Pharmacometrics, and work with leaders in Non-Clinical Safety, Bioanalytical and CMC functions to enable successful drug approval. The PCO organization is a multi-disciplinary department whose cross-functional teams apply deep expertise in DMPK, toxicology, pharmaceutics and bioanalysis to identify and solve issues, discover high quality drug candidates and enable their clinical development.

Key Responsibilities

• Lead research efforts and overall effectiveness of the Development DMPK group, consisting of approximately 25 people, including Ph.D. scientists and research associates (BS or MS training), with some scientists working in locations other than Lawrenceville, NJ.
• Provide strategic direction, development and implementation of work efforts within the group and managing resources within the group to meet the department goals.
• Ensure effective regulatory progression of development candidates by engaging directly with regulatory authorities and/or providing guidance for regulatory discussions across the DMPK team.
• Represent Development DMPK in strategic meetings and discussions across Development project teams and with Global Drug Development leadership
• Oversee the review and approval for all regulatory documents (IND, NDA, BLA, MAA, etc) prepared by the Development DMPK team.
• Interface with the early development teams and Clinical Pharmacology to ensure effective engagement and timely study conduct for entire portfolio; interface with scientists in PCO and non-clinical safety to coordinate effective DMPK data packages for IND submissions.
• Demonstrate leadership consistent with the our philosophy, including attracting and retaining top key talent critical to business success, developing team members to support the portfolio including identification of new skills and approaches to DMPK research.

Education/Experience

• Ph.D. degree in any area of drug disposition, with emphasis on metabolism, pharmacokinetics or biochemical toxicology, with experience in drug discovery and development.
• At least 15 years of experience in conducting and leading research efforts in drug metabolism and pharmacokinetics; preference to scientists who are familiar with advancing candidates through development, with knowledge of regulatory requirements for all DMPK issues and a proven track record of effective interactions with health authorities.
• Outstanding problem-solving skills, with proven ability to integrate across disciplines to address issues and identify mitigation strategies.
• Highly effective written and oral communication skills including contributions to the published literature, and a track record of successful regulatory submissions.
• Strong interpersonal skills with evidence for effective management of a dynamic team and commitment to professional development of all personnel.

Job Type: Full-time

Work Location: On the road