Director, Clinical Pharmacology

The Director, Clinical Pharmacology acts as the primary clinical pharmacology lead providing clinical pharmacology expertise to a multidisciplinary study team. The Associate Director/Director, Clinical Pharmacology is responsible for clinical pharmacology programs for assigned projects and will be the key expert on all clinical pharmacology & pharmacometrics matters relating to assigned projects. The Associate Director, Clinical Pharmacology will work in close collaboration with different functions including non-clinical, Research, Regulatory, BioMetrics and Clinical. This position reports into the Pharmacology and Toxicology organization.¬ ¬
Responsibilities, including but not limited to:
  • Evaluate and perform hands-on analysis of clinical PK/PD data; authorize PK clinical study reports
  • Provide PK/PD modeling to support dosing strategies for clinical programs
  • Contribute to clinical pharmacology strategy and planning for clinical programs
  • Provide mentorship and guidance to junior scientists with potential supervisory role
  • Ensure timely and accurate communication of study results and interpretation to appropriate internal drug development teams
  • Write and edit dose rationale sections of clinical protocols and investigator brochures
  • Maintain a current understanding of small and large molecule PK literature and methodology, as well as the scientific literature related to the specific drug discovery projects
  • Ensure appropriate quality of documentation for internal department studies compatible with global regulatory submission requirements
Technical Requirements & Skills:
  • PhD or equivalent in pharmacokinetics, pharmacology or pharmaceutical science is required; industry experience in conducting clinical stage drug development is strongly preferred
  • Must be proficient with hands-on PK NCA analysis and data reporting using Phoenix WinNonlin
  • Population PK/PD analysis using NONMEM or NLME is desired; PBPK modeling experience is a plus
  • Demonstrated understanding and experience in clinical pharmacology is required
  • Experience in writing ADME and/or Clinical Pharmacology sections of regulatory submission documents
  • Experience evaluating the pharmacokinetic properties of therapeutic antibodies is preferred
  • Experience in working as a PI with external CROs with timely delivery of clear and accurate well written study findings
  • Strong knowledge of clinical drug development and FDA and ICH guidance documents is essential
People Management Skills:
  • Clarify Direction & Priorities: Set clear direction for your direct reports aligned with functional and corporate goals. Reprioritize work, as needed. Enable others to do their job well by communicating information and making decisions in a clear, timely manner.
  • Partner & Collaborate Effectively: Listen to and value others‚ thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.
  • Support Learning & Growth: Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others.¬

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