Alkermes · 2 months ago
Associate Director, Clinical Pharmacology
Greater Boston
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$180K/yr - $195K/yr
6+ years expAlkermes is a fully-integrated, global biopharmaceutical company focused on developing medicines for complex psychiatric and neurological disorders. They are seeking a quantitative clinical pharmacologist to support the CNS therapeutic area, responsible for selecting optimal doses and dosage regimens, contributing to clinical program design, and serving as a liaison across various teams.
BiotechnologyHealth CarePharmaceutical
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 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
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 molecule in a variety of clinical investigation paradigms is desired. Direct experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME are desirable attributes
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, this person will be relied upon to act independently, within a highly matrixed clinical development organization and must have the experience and conviction to provide sound clinical pharmacology related input to the project teams
Qualification
Required
Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 6+ years or 10+ years of experience in pharmaceutical industry
A strong background in clinical pharmacology, pharmacokinetics and modeling combined with excellent leadership and communications skills
Clinical pharmacology experience with small molecule in a variety of clinical investigation paradigms
Direct experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME
Ability to function in a highly matrixed team environment
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
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, this person will be relied upon to act independently, within a highly matrixed clinical development organization and must have the experience and conviction to provide sound clinical pharmacology related input to the project teams
Preferred
Demonstrated experience in serving as clinical pharmacology lead on development programs
The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools
Sound working knowledge of the cross-function interfaces that are important for efficient drug development, and a detailed understanding of non-clinical and clinical DMPK processes
Programming experience (e.g., NONMEN, Phoenix NLME, Monolix, R, WinNonlin, SAS, Splus etc. is desirable
Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required
Experience in non-compartment 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
Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required
Benefits
Annual performance pay bonus
Competitive benefits package
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
2026-01-13
2026-01-09
Company data provided by crunchbase