Director, Clinical Pharmacology
Alkermes
July 02, 2026
On-site
Greater Boston
Clinical Research and Development
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; accountable for dose selection and optimization across all development stages.
- Design and execute clinical pharmacology strategies integrating PK/PD principles, quantitative modeling/simulation, translational sciences, and nonclinical ADME/DMPK data.
- Lead clinical pharmacology components of regulatory submissions; contribute to health authority interactions.
- Contribute to clinical program design, trial protocols, analysis plans, study reports, and regulatory submissions.
- Conduct and oversee pharmacokinetic (NCA) analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modeling.
- Present and defend model-based approach outcomes to internal governance boards and regulatory agencies.
- Write or review clinical pharmacology components of regulatory documents and responses; participate in regulatory interactions.
- Promote model-informed drug discovery/development via external collaboration, journal publication, and conference presentations.
- Function effectively in a highly matrixed team environment.
Qualifications:
- Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with at least 10 years of clinical pharmacology experience in the pharmaceutical industry.
- Demonstrated experience serving as clinical pharmacology lead on development programs.
Preferred Qualifications/Skills:
- Strong understanding of clinical pharmacology, biopharmaceutics, and pharmaceutical sciences.
- Working knowledge of cross-functional interfaces and detailed understanding of clinical pharmacology/PK.
- Programming experience (e.g., NONMEN, Phoenix NLME, R, WinNonlin).
- Current knowledge of FDA guidance related to DMPK and clinical pharmacology; direct FDA interaction experience, including IND/NDA submissions.
- Experience with non-compartment and model-based PK and PK/PD analyses; inclusion of data in manuscripts, study reports, and regulatory submission documents (IND/NDA/CTD).
- Scientific writing and presentation skills; peer-reviewed publications required.
- Strong interpersonal, leadership, communication, and time-management skills; experience managing internal/external personnel.
Onsite requirement: Onsite 3x/week in Waltham, MA.
Compensation/Benefits:
- Annual base salary: $228,000–$246,000; eligible for annual performance pay bonus; competitive benefits package.
- 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; accountable for dose selection and optimization across all development stages.
- Design and execute clinical pharmacology strategies integrating PK/PD principles, quantitative modeling/simulation, translational sciences, and nonclinical ADME/DMPK data.
- Lead clinical pharmacology components of regulatory submissions; contribute to health authority interactions.
- Contribute to clinical program design, trial protocols, analysis plans, study reports, and regulatory submissions.
- Conduct and oversee pharmacokinetic (NCA) analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modeling.
- Present and defend model-based approach outcomes to internal governance boards and regulatory agencies.
- Write or review clinical pharmacology components of regulatory documents and responses; participate in regulatory interactions.
- Promote model-informed drug discovery/development via external collaboration, journal publication, and conference presentations.
- Function effectively in a highly matrixed team environment.
Qualifications:
- Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with at least 10 years of clinical pharmacology experience in the pharmaceutical industry.
- Demonstrated experience serving as clinical pharmacology lead on development programs.
Preferred Qualifications/Skills:
- Strong understanding of clinical pharmacology, biopharmaceutics, and pharmaceutical sciences.
- Working knowledge of cross-functional interfaces and detailed understanding of clinical pharmacology/PK.
- Programming experience (e.g., NONMEN, Phoenix NLME, R, WinNonlin).
- Current knowledge of FDA guidance related to DMPK and clinical pharmacology; direct FDA interaction experience, including IND/NDA submissions.
- Experience with non-compartment and model-based PK and PK/PD analyses; inclusion of data in manuscripts, study reports, and regulatory submission documents (IND/NDA/CTD).
- Scientific writing and presentation skills; peer-reviewed publications required.
- Strong interpersonal, leadership, communication, and time-management skills; experience managing internal/external personnel.
Onsite requirement: Onsite 3x/week in Waltham, MA.
Compensation/Benefits:
- Annual base salary: $228,000–$246,000; eligible for annual performance pay bonus; competitive benefits package.