Senior Director, Clinical Pharmacology

Senior Director, Clinical Pharmacology Job Description Template

Our company is looking for a Senior Director, Clinical Pharmacology to join our team.

Responsibilities:

  • Contribute to the preparation of the clinical pharmacology sections of pre-IND, IND, IB, IMPD and other regulatory documents;
  • Lead assessments of relevant exposure vs. response data for supporting dose selection during and post POC;
  • Accountable for the pharmacokinetic and PK/PD data analyses using WinNonlin, NONMEM and/or other software for such analyses;
  • Contribute to the design of late-stage clinical trials to ensure that project goals are met;
  • Represent the Clinical Pharmacology function at meetings with regulatory agencies;
  • Conduct clinical pharmacology-based assessment of in-licensing opportunities;
  • Contribute to the design of early phase clinical trials (FIH to POC) and ensure that project goals are met;
  • Responsible for the preparation of clinical PK/PD reports and/or clinical PK/PD sections of the CSRs.

Requirements:

  • Strong analytical skills and ability to interpret complex pre-clinical clinical data sets;
  • Proven track record of delivery of successful drug development programs and/or regulatory submissions;
  • Software experience in WINNONLIN, NONMEM, SAS, JMP, S-Plus, and/or R;
  • Proven senior leadership and strong external presence.