Director, Clinical Pharmacology

AlkermesWaltham, MA
Hybrid

About The Position

We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting CNS therapeutic area as a key member of Clinical Pharmacology, DMPK and BA department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams. The Clinical Pharmacology Director provides strategic, scientific, and operational leadership for clinical pharmacology activities at the program level. This role serves as the primary clinical pharmacology representative on cross‑functional development teams and is accountable for dose selection and optimization across all stages of development. The Director will design and execute clinical pharmacology strategies by integrating PK/PD principles, quantitative modeling and simulation, translational sciences, and nonclinical ADME/DMPK data. Responsibilities include leading clinical pharmacology components of regulatory submissions, contributing to health authority interactions, and leading Clinical Pharmacology study design and execution. This role is hybrid and requires the person to be onsite 3x a week in our Waltham, MA office.

Responsibilities

  • Provide strategic, scientific, and operational leadership for clinical pharmacology activities at the program level.
  • Serve as the primary clinical pharmacology representative on cross‑functional development teams and is accountable for dose selection and optimization across all stages of development.
  • Design and execute clinical pharmacology strategies by integrating PK/PD principles, quantitative modeling and simulation, translational sciences, and nonclinical ADME/DMPK data.
  • Lead clinical pharmacology components of regulatory submissions
  • Contribute to health authority interactions
  • Lead Clinical Pharmacology study design and execution.
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