Director, Clinical Pharmacology
Alkermes
1 month ago
Remote friendly (Greater Boston)
United States
Clinical Research and Development
Responsibilities:
- Serve as Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams.
- Provide strategic, scientific, and operational leadership for program-level clinical pharmacology activities.
- Design and execute clinical pharmacology strategies integrating PK/PD, quantitative modeling and simulation, translational sciences, and nonclinical ADME/DMPK data.
- 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 approaches to internal governance boards and regulatory agencies.
- Write or review clinical pharmacology components of regulatory documents/responses and participate directly in regulatory interactions.
- Promote model-informed drug discovery and development via external collaboration, journal publication, and conference presentations.
- Function effectively in a highly matrixed team environment.
Qualifications:
Basic:
- 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:
- Strong understanding of clinical pharmacology, biopharmaceutics, and pharmaceutical sciences.
- Sound working knowledge of cross-function interfaces for efficient drug development and detailed understanding of clinical pharmacology/pharmacokinetic components.
- Programming experience (e.g., NONMEN, Phoenix NLME, R, WinNonlin).
- Current knowledge of FDA regulatory guidance related to DMPK/clinical pharmacology; direct FDA interaction including submission of IND, NDA, and other regulatory documents.
- Experience with non-compartment and model-based PK and PK/PD analyses; inclusion of data in manuscripts, study reports, and regulatory submission sections (INDs, NDAs, CTDs).
- Scientific writing and presentation skills; peer-reviewed publications.
- Strong interpersonal, leadership, communication, and time-management skills; demonstrated management of internal and external personnel (outsourced projects).
Work Model:
- Hybrid; onsite 3x a week in Waltham, MA.
Compensation/Benefits (as stated):
- Annual base salary: $228,000–$246,000; eligible for annual performance pay bonus; competitive benefits package.
- Serve as Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams.
- Provide strategic, scientific, and operational leadership for program-level clinical pharmacology activities.
- Design and execute clinical pharmacology strategies integrating PK/PD, quantitative modeling and simulation, translational sciences, and nonclinical ADME/DMPK data.
- 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 approaches to internal governance boards and regulatory agencies.
- Write or review clinical pharmacology components of regulatory documents/responses and participate directly in regulatory interactions.
- Promote model-informed drug discovery and development via external collaboration, journal publication, and conference presentations.
- Function effectively in a highly matrixed team environment.
Qualifications:
Basic:
- 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:
- Strong understanding of clinical pharmacology, biopharmaceutics, and pharmaceutical sciences.
- Sound working knowledge of cross-function interfaces for efficient drug development and detailed understanding of clinical pharmacology/pharmacokinetic components.
- Programming experience (e.g., NONMEN, Phoenix NLME, R, WinNonlin).
- Current knowledge of FDA regulatory guidance related to DMPK/clinical pharmacology; direct FDA interaction including submission of IND, NDA, and other regulatory documents.
- Experience with non-compartment and model-based PK and PK/PD analyses; inclusion of data in manuscripts, study reports, and regulatory submission sections (INDs, NDAs, CTDs).
- Scientific writing and presentation skills; peer-reviewed publications.
- Strong interpersonal, leadership, communication, and time-management skills; demonstrated management of internal and external personnel (outsourced projects).
Work Model:
- Hybrid; onsite 3x a week in Waltham, MA.
Compensation/Benefits (as stated):
- Annual base salary: $228,000–$246,000; eligible for annual performance pay bonus; competitive benefits package.