Senior Director, Clinical Pharmacology

or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 8+ years of relevant industry experience in Clinical Pharmacology.

Prior experience with small molecules oncology drug development.

Familiar with FDA’s Project Optimus guidance.

Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology.

Hands-on experience with WinNonlin and Clin Pharm study designs.

Strong understanding of DMPK, CMC and Toxicology and related regulatory guidance is required.

We are seeking a passionate and experienced Clinical Pharmacologist with strong early development background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization.

As a member of the Early Development Clinical Pharmacology group, you will:

Provide strategic insight and technical leadership within the Clinical Pharmacology function.

Author technical reports and/or regulatory documents for major milestones of clinical development, specifically IND, EOP1 & EOP2 Briefing Documents.

Participate in regulatory interactions and responses to regulatory questions.

Apply state-of-the-art quantitative modeling, including translational PK/PD, population PK, and exposure-response analyses, to guide recommended phase 2 dose/schedule (RP2Ds) selection for pivotal studies.