Director, Clinical Pharmacology

Alkermes, Inc.; Waltham (MA); Hybrid; USD 130,000 - 180,000; Full time

Job summary

A biopharmaceutical company in Waltham is seeking an experienced Clinical Pharmacology Director to lead strategies and support the CNS therapeutic area. This position requires extensive knowledge in clinical pharmacology, oversight of regulatory submissions, and integration of PK/PD principles. The role is hybrid, requiring onsite work three times a week, and focuses on strategic leadership and dose optimization across development stages.

Qualifications

• Extensive knowledge in clinical pharmacology and CNS therapeutic area.
• Expertise in regulatory submissions and dose optimization.
• Strong background in PK/PD principles and quantitative modeling.

Responsibilities

• Provide strategic leadership in clinical pharmacology activities.
• Lead design and execution of clinical pharmacology strategies.
• Accountable for dose selection throughout development stages.

Job description

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.