Director, Clinical Operations

The Director of Clinical Operations in the Discovery Medicine and Pharmaceutical Sciences plays a central role in the execution of Phase 1 clinical studies conducted in healthy volunteers at Alkermes. This role provides operational leadership for healthy volunteer studies across the clinical development lifecycle, ensuring studies are conducted in compliance with GCP, FDA regulations, ICH guidelines, company SOPs, and project timelines.

The Director will partner closely with Clinical Pharmacology, Translational Medicine, Medical, Biometrics, Regulatory Affairs, Clinical Supply, Quality Assurance, Pharmacovigilance, and CRO partners to ensure successful execution of first-in-human (FIH), SAD, MAD, food effect, relative bioavailability, DDI, QTc, and other early development studies in healthy volunteers.

The successful candidate will be responsible for study budgets, forecasting, resource planning, operational strategy, inspection readiness, eTMF oversight, vendor management, and continuous process improvement and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

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.

Degree LevelBachelor's Degree