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Director, Clinical Pharmacology

Alkermes - Waltham, MA, United States

Posted Apr 6, 2026

Benefits

Parental leave
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Non-birth-parent leave
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Family-building benefits
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Verification
Not verified last checked Jun 13, 2026
Salary
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401(k) match
Listed Source: EMPLR_CONTRIB_INCOME_AMT. source Last checked Jun 13, 2026.

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Schedule

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Weekend work
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Application

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About this role

Director, Clinical Pharmacology Waltham, MA, United States 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. Essential Areas of Responsibility: Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions Conducting and overseeing pharmacokinetic (NCA) analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modelling Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies Write or review clinical pharmacology components of regulatory documents and responses as well as participate directly in regulatory interactions Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation

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