Director of Clinical Pharmacology (GK)
Job Location: Ridgewood, NJ (see all jobs in NJ)
Work Type: Hybrid
Date Posted: 2021-12-16
Director of Clinical Pharmacology
Ridgewood, NJ (Hybrid)
Function as Clinical Pharmacology subject matter expert, interfacing with and leading multidisciplinary study teams for multiple clinical programs. Perform and/or oversee analysis of PK data and ensure quality population PK or PK/PD modeling and simulation analyses. Design and interpret early phase clinical studies/clinical programs. Contribute to appropriate design of clinical study protocols and review of clinical study reports. Involvement in dose selection for Phase 1, 2 and 3 studies. Interface with cross-functional teams, including preclinical, statisticians, clinical operations, MDs, and regulatory affairs teams. Preparation of regulatory documents (INDs, NDAs, and IBs) as needed.
PhD degree in Pharmaceutical Sciences or related discipline required. 8+ years of industry experience and a proven track record within the duties mentioned above with a background in PK and PD. 4+ years of experience managing clinical pharmacology programs. Expert in compartmental/non-compartmental analyses. Strong experience with CP and statistical software, including but not limited to NONMEM and R. Excellent written and verbal communication skills.
Please contact Greg Kane at email@example.com
Recruiter LinkedIn Page