Senior Director, DMPK and Bioanalysis

Job Description

We have an exciting opportunity at Alkermes, Inc. for an experienced and visionary leader to join our team as the Senior Director of Drug Metabolism and Pharmacokinetics (DMPK) and Regulated Bioanalysis. In this role, you will drive strategic direction, oversee scientific excellence, and ensure compliance in DMPK and bioanalytical activities to support drug discovery and development programs. This position requires a dynamic individual with a proven track record in leading cross-functional teams, managing external collaborations, and delivering high-quality data for regulatory submissions. This role provides rare opportunity for an individual to develop their skills through collaboration with the senior most levels of the organization while making strategic and tactical impact on driving our science to help patients.

Responsibilities:

• Develop and execute DMPK and bioanalytical strategies to optimize preclinical models and inform first-in-human clinical dosing strategies.
• Review preclinical study reports and prepare submission documentation in collaboration with Pharmacology/DMPK colleagues.
• Oversee the design, execution, and interpretation of ADME, PK/PD, and bioanalytical studies to meet project goals and timelines.
• Identify and manage consultants and vendors to support DMPK and regulated bioanalytical studies.
• Ensure adherence to timelines and budgets for DMPK deliverables, supporting seamless execution.
• Collaborate cross-functionally with discovery, medicinal chemistry, toxicology, clinical pharmacology, and external partners to integrate DMPK and bioanalytical data into drug development plans.
• Provide scientific and technical leadership for regulated bioanalysis, including method development, validation, and sample analysis for small molecules.
• Prepare regulatory documents (e.g., IND, NDA, BLA) and represent the company in regulatory interactions.
• Stay current with advancements in DMPK, bioanalytical technologies, and regulatory guidelines to maintain best practices.
• Mentor and develop a high-performing team, fostering innovation, collaboration, and continuous learning.
• Manage departmental budgets, resources, and timelines effectively.

Leadership Competencies:

• Engender trust and respect through open, honest communication with peers, colleagues, and senior leaders.
• Mentor and coach team members to build capability and sustain scientific excellence.

Basic Requirements:

• Education: MS with 15+ years or Ph.D. with 10+ years in pharmacokinetics, pharmaceutical sciences, or related disciplines, with 10+ years of bio/pharmaceutical industry experience in DMPK and BA.

Preferred Requirements:

• DMPK and BA Expertise: Strong understanding of DMPK and BA principles, drug development processes, and regulatory guidance to support DMPK and early Clinical Pharmacology strategies.
• Regulatory Submissions: Proven experience preparing DMPK and BA sections of regulatory documents (e.g., pre-IND, IND, IB, clinical study reports, CTA, filing documents) and collaborating with cross-functional teams.
• Small Molecules: Preferred experience in regulatory submissions focused on preclinical and clinical development strategy and execution.
• Skills: Strong judgment, problem-solving, analytical, and organizational skills, with attention to detail.
• Regulatory Knowledge: In-depth understanding of FDA/EMA/ICH GLP requirements and clinical bioanalytical data management, including data transfer, analysis, and reporting.
• Management: Prior experience managing laboratories and vendors with excellent organizational, multi-tasking, and communication abilities.
• Interpersonal: Collaborative mindset and ability to thrive in a matrixed environment.
• Communication: Exceptional written and verbal communication skills, with experience presenting to project teams and executive leaders.

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

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.