Job Category: Clinical & Statistics

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)
200-230K base

RESPONSIBILITIES:
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.

QUALIFICATIONS:
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 gkane@clarkdavis.com

200-230K base

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