Senior Director, Clinical Pharmacology

The Opportunity:

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.

• Work with the Discovery organization to support assets in the IND-enabling stage, including collaboration with DMPK and Toxicology groups in assessment of human start dose and assessment of the need for human DDI studies.

• Work with the Clinical Development team in designing FIH study.

• Design and report Clin Pharm studies such as hADME, Food-Effect and DDI studies.

• Engage and work with CROs on clinical pharmacology activities.

• Represent the Clinical Pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.

Required Skills, Experience and Education:

• A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 8-10 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.

• Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.

• A critical thinker and passionate team player and quick learner with high energy who thrives in a dynamic and fast-paced environment.

• Prior management experience.

Preferred Skills:

• Prior experience interacting with FDA on dose optimization.

• Hand-on experience with PBPK models.

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