Associate Director, DMPK
The successful candidate will provide strategic leadership to support Discovery, Early Stage Clinical and/or Clinical Development programs as representative of the DMPK team. He/she will work cross-functionally on project teams, providing scientific leadership and strategic DMPK guidance across teams focused on small molecules and biologics targeting oncology and CNS diseases. Responsibilities include developing DMPK plans (e.g., ADME assays to support discovery to candidate nomination, planning and implementing preclinical strategy for predicting human efficacious dose for FIH clinical trials, planning and overseeing DMPK studies to support clinical programs; etc.). He/she must demonstrate intellectual curiosity and strong capability to analyze, integrate and interpret data from in vitro ADME and PK studies that will enable project teams to optimize drug design leading to clinical candidate selection and nomination.
He/she will also be required to stay current with the latest in technological and regulatory advances in the DMPK arena and demonstrate strong interest and expertise in PK analysis and PK/PD modeling. This role will involve developing and writing protocols, study reports and sections of regulatory documents (IMPD, IB, IND, NDA, etc.). The management of CRO activities is also part of the duties for this position. The individual will perform other tasks and assignments as needed and specified by management.
- A Ph.D. degree with 8+ years or a M.S. with 15+ years of industrial experience in Pharmacokinetics, Pharmacology, Pharmaceutics or related disciplines.
- Work experience representing DMPK disciplines with a project team is essential.
- The position requires in-depth knowledge of ADME as well as pharmacokinetics, compartmental and non-compartmental analysis of small molecules.
- Strong knowledge of PBPK & PK/PD modeling of small molecules is a plus.
- Strong organization, multi-tasking and communication skills are key attributes of the successful candidate.
- A strong understanding of regulatory guidelines for DMPK packages to support drug development.
- Ability to integrate complex data from multiple sources into a rational understanding of drug disposition.
- The ability to work as an effective team member in highly collaborative and fast-paced work environment, and the ability to lead and influence are highly desirable.