The Senior Director, Clinical Pharmacology will co-function as a subject matter expert supporting all nonclinical, DMPK and clinical pharmacology development for small molecule oral drugs in development in the Oncology therapeutic area. The Senior Director, Clinical Pharmacology will co-determine and execute on strategy for DMPK and clinical pharmacology studies, including an assessment of required studies, gap analysis, vendor selection and oversight, and data interpretation. This individual will develop strategy and work with vendors on clinical pharmacology studies including BA/BE, DDI, popPK, PBPK and E-R modeling. This role will include the co-authoring of nonclinical, PK and clinical pharmacology modules of NDA, MAA, etc. This is a remote-based position.
- Works independently and with project teams to develop and execute clinical pharmacology development programs, PK/PD modeling and/or bioanalysis of PK samples
- Analyze, summarize and interpret nonclinical and clinical pharmacology data and/or integrate study results into the ongoing clinical development strategy
- Co-manage external vendors/CROs involved in the clinical studies
- Aid in the design plans to support regulatory filings such as eCTD/NDA etc.
- Participate in authoring and review of PK and clinical pharmacology sections of regulatory documents (e.g., protocols, SAPs, CSRs, IBs) and responses to regulatory agencies
- PhD in pharmacokinetics, clinical pharmacology, pharmacometrics, drug metabolism, pharmacology or related discipline
- 15 years overall experience including 5 to 7+ years of research and development experience with at least 5 years within the pharmaceutical industry, at least some of which has been in start-up environment, with demonstrated experience in advancing clinical pharmacology studies through clinical development
- Must be hands-on as well as strategic
- Proven solid experience with managing clinical pharmacology vendors/CROs
- Hands-on experience with population PK, PBPK and E-R modeling
- Hands-on experience in co-directing strategy and authoring nonclinical, PK and clinical pharmacology modules of NDA and MAA
- Oncology small molecule experience preferred
- Excellent oral and written communication skills
- Strong leadership skills preferred