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 requires the person to be onsite 3x a week in our Waltham, MA office.

Responsibilities

Essential Areas of Responsibility:

• 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. 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, 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

Qualifications

Basic Qualifications:

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

Preferred Qualifications:

• PK Experience: The incumbent should have a strong understanding of clinical pharmacology, biopharmaceutics, and pharmaceutical sciences.
• Knowledge: Sound working knowledge of the cross-function interfaces that are important for efficient drug development, and a detailed understanding of clinical pharmacology/pharmacokinetic components.
• Programming experience (e.g., NONMEN, Phoenix NLME, R, WinNonlin etc. is desirable.
• Regulatory: 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 is required.
• Writing: 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. Scientific writing and presentation skills are essential; peer reviewed publications in a relevant field 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. Additional details can be found on our careers website: www.alkermes.com/careers#working-here

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