Associate Director, Clinical Pharmacology

Job title: Associate Director, Clinical Pharmacology
Reports to: VP, Research & Development

Job purpose:

In this role the successful candidate will be responsible for leading the design and execution of Clinical Pharmacology and M&S strategies.

Duties and responsibilities:

  • As a Clinical Pharmarmacology leader, supports development project teams across diverse therapeutic areas that contribute to the project strategies
  • Responsible for managing the design and implementation of the Clinical Pharmacology and Modeling & Simulation (M&S) strategies from Phase 1 to pivotal Ph2/3 clinical studies with support of external consultants/advisors
  • Apply/guide M&S approaches to ensure development of safe and effective dosing regimens for various patient populations & ensure optimal drug development
  • Supervise non-compartmental pharmacokinetic (PK), Population PK and PK/PD analyses
  • Additional responsibilities include assisting in preparing and reviewing bioanalytical plans, protocols, and reports to meet regulatory requirements and management of bioanalytical activities (budgeting, auditing CROs, setting up agreements, etc)
  • Leads clinical pharmacology study efforts (e.g. study design, protocol preparation, clinical phase oversight and reporting). Analyzes and interprets results and recommends action based on study results
  • Directs planning of all relevant PK-PD analyses; guides such analyses as appropriate. Works to ensure population PK, PK-PD modeling and simulation, meta-analysis, etc. are integrated into the development plan
  • Responsible for appropriately summarizing and interpreting results of PK and/or PK/PD analyses with respect to their impact on development and clinical use of drugs
  • Supports regulatory strategy for filings and is responsible for clinical pharmacology sections of regulatory documents. Contributes or leads the resolution of clinical pharmacology queries from regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries
  • Analyze, interpret, summarize and present data to internal project teams, senior management and/or global health authorities, as applicable
  • Contribute towards development of IND/CTA filings, including NDA submissions, Investigator Brochure and other regulatory documents

Qualifications include but not limited to:

  • PhD in pharmacokinetics or pharmaceutical sciences, or PharmD
  • 6+ years of relevant experience in Clinical Pharmacology in the pharmaceutical industry (level commensurate with experience)
  • Demonstrated track record and ability to lead/manage the clinical pharmacology / pharmacokinetic components of development projects
  • Experience in leading the design and execution of Clinical Pharmacology and M&S strategies
  • Working knowledge of common tools such as WINNONLIN, Simcyp, R, SAS (NONMEM, a plus)
  • Must have a good understanding of bioanalytical technology/methods and problem-solving
  • Excellent critical thinking, scientific and interpersonal skills, including a demonstrated ability to analyze, interpret and report complex PK/PD data
  • Proven ability to work/collaborate in a matrix environment and develop relationships with key stakeholders
  • Excellent written/oral communication and presentation skills

Travel: 10%

Candidates must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.

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