Director, Bioanalysis Clinical Development and Research at Alkermes, Inc. in Waltham, MA

We are seeking an experienced and dynamic Director of Bioanalysis supporting both research and clinical development programs.

Leadership: Serve as the bioanalytical lead on project teams, supporting both Research and Clinical Development programs. This role involves a combination of hands-on laboratory work and clinical bioanalytical (BA) support.
- Approximately 60% of the role will focus on clinical BA support, and 40% on discovery BA work using LC-MS/MS in the lab.
Compliance: Lead audits and evaluation of bioanalytical CROs to ensure GLP, GCP, and non-GLP studies comply with regulatory standards.
Oversight: Provide scientific and technical oversight to bioanalytical vendors or CROs for method optimization, assay transfer, qualification/cross validation, sample analysis, and delivery of results within project timelines.
Strategic Input: Contribute strategic and scientific insights to program teams on bioanalytical approaches and planning.
Project Management: Effectively manage multiple projects, proactively resolving issues and keeping teams and leadership informed of critical developments.
Reporting: Ensure internal research reports are complete, accurate, and at the same time clinical BA reports meet regulatory filing requirements. Contribute to clinical study reports (CSR) and regulatory documents (IND, IB, NDA).
Client Communication: Address client needs and ensure satisfaction.
Advisory Role: Advise on the development and optimization of bioanalytical technologies, strategies, and models.
Collaboration: Partner with Clinical Pharmacology, DMPK, Discovery, Pharmaceutical Development, Clinical Operations, Toxicology, and Clinical Development colleagues to manage external vendor support.
Technical knowledge: Keep current with bioanalytical and regulatory guidance (FDA, EMA, and ICH) in bioanalytical chemistry.
Work Environment: This is an on-site position.

Qualifications

Education: MS with 15+ years or Ph.D. with 10+ years in developing LC/MS/MS and other chromatography-based assays for small molecule and biomarker quantitation.
Experience: Proven experience in developing bioanalytical methods with stable and radiolabelled materials. Strong knowledge of "fit-for-purpose" assay development in research and regulated bioanalysis for drug development. Experience in developing assays in house to support research, quantifying, and transferring methods to CROs.
Hands-on lab experience to work on discovery assets
Technical Skills: Proficiency with ELN, web-based applications, WinNonlin, and other IT tools.
Regulatory Expertise: In-depth knowledge of FDA/EMA/ICH GLP requirements and clinical bioanalytical data management (GLP and non-GLP), including data transfer, analysis, and reporting.
Management Skills: Prior experience in laboratory and/or vendor management. Strong organizational, multi-tasking, and communication skills.
Regulatory Writing: Experience in regulatory writing for bioanalytical chemistry, leading 2.7.1, presentations, and preparation of regulatory filings.
Interpersonal Skills: Strong collaborative skills and experience in a matrixed environment.
Communication: Exceptional oral and written communication skills, with experience presenting to project teams and executive leaders.

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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.