Director, Clinical Pharmacology

Alkermes; Boston (MA); Hybrid; USD 228,000 - 246,000; Full time

Benefits offered by this job

Annual performance-pay bonus

Competitive benefits package

Job summary

A leading biopharmaceutical company based in Waltham, MA seeks a Clinical Pharmacology Director to provide strategic and operational leadership in clinical pharmacology. The role involves designing clinical strategies and overseeing regulatory submissions. The ideal candidate has a Ph.D. or Pharm D with over 10 years of experience and knowledge in pharmacokinetics. The position is hybrid, requiring onsite presence three times a week, and offers a competitive salary ranging from $228,000 to $246,000, plus performance bonuses.

Qualifications

• At least 10 years of clinical pharmacology experience in the pharmaceutical industry.
• Experience serving as clinical pharmacology lead on development programs.
• Demonstrated scientific writing and presentation skills.

Responsibilities

• Lead clinical pharmacology components of regulatory submissions.
• Design and execute clinical pharmacology strategies.
• Conduct pharmacokinetic analysis and dose selection.

Skills

Leadership

Communication

Pharmacokinetic modeling

CNS therapeutics knowledge

Education

Ph.D. or Pharm D in Pharmaceutical Sciences

Tools

NONMEM

Phoenix NLME

R

WinNonlin

Job description

Job Description

We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting the CNS therapeutic area as a key member of the Clinical Pharmacology, DMPK, and BA departments. The candidate will represent as the 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

• 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 outcomes 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
• Ability to function in a highly matrixed team environment

A strong background in clinical pharmacology, pharmacokinetics and modeling combined with excellent leadership and communications skills are essential in this dynamic role. Clinical pharmacology experience with small molecules in a variety of clinical investigation paradigms is desired. Direct experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME are desirable attributes. Knowledge of, and immediate experience in CNS therapeutics is desired.

The candidate is expected to be an active contributor to the multi‑disciplinary project teams, providing innovative and progressive thinking to projects and, where appropriate, guidance to other team members. Upon completion of on‑boarding, the candidate will act independently within a highly matrixed clinical development organization and provide sound clinical pharmacology input to the project teams.

Qualifications

Basic Qualifications

• Education: Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or a related field with at least 10 years of clinical pharmacology experience within the pharmaceutical industry. Demonstrated experience in serving as a clinical pharmacology lead on development programs.

Preferred Qualifications

• Strong understanding of clinical pharmacology, biopharmaceutics, and pharmaceutical sciences.
• Sound working knowledge of cross‑function interfaces that are important for efficient drug development, and a detailed understanding of clinical pharmacology/pharmacokinetic components.
• Programming experience (e.g., NONMEM, Phoenix NLME, R, WinNonlin, etc.) is desirable.
• Current knowledge of FDA regulatory guidance related to DMPK and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents.
• Experience in non‑compartmental and model‑based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (e.g., INDs, NDAs, CTDs) is required. Scientific writing and presentation skills are essential; peer‑reviewed publications in a relevant field are required.
• Excellent interpersonal, leadership, communication and time‑management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.

The annual base salary for this position ranges from $228,000 to $246,000. In addition, this position is eligible for an annual performance‑pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.

Equal Employment Opportunity

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service, or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E‑Verify employer.