We are currently seeking an Associate Director, Clinical Research Scientist (CRS) to join our Clinical Development Group. This position will report to the Senior Medical Director and play a role in the design, execution, and oversight of clinical trials in the CNS space.
ResponsibilitiesLead clinical data review activities for assigned studies or programs, ensuring data quality and timely identification of key findings.
Support DSMB activities, including preparation of materials and interpretation of outputs.
Contribute to the development of clinical study protocols, ensuring alignment with program objectives and regulatory requirements.
Partner with cross-functional teams to define study endpoints, inclusion/exclusion criteria, and research methodologies.
Oversee the selection and validation of clinical outcome measures and data collection methods.
Conduct comprehensive literature reviews to support clinical trial design and development plans.
Summarize and present clinical data and insights to cross-functional teams; contribute to leadership presentations as needed.
Contribute to the creation and execution of clinical development plans spanning early to late-phase development (Phase 1-3).
Research opportunities for new indications for a given molecule.
Provide scientific input into regulatory documents and support health authority interactions, including FDA communications.
Monitor the competitive landscape and emerging science in CNS/neurology, sharing relevant insights with the team.
Contribute to scientific publications, including abstracts, manuscripts, and presentations at medical conferences.
Establish and maintain relationships with key opinion leaders (KOLs), clinical investigators, and external experts.
Advanced degree (Ph.D. or Pharm.D.) in a neuroscience or a related field.
Minimum of 6-8 years of experience in clinical research within the pharmaceutical or biotechnology industry, with demonstrated experience in clinical trial design and execution.
Strong expertise in neurology and CNS disorders.
Proven track record of leading clinical research initiatives and contributing to strategic development plans.
Experience interacting with clinical investigators, and key medical experts.
Strong knowledge of ICH, GCP and other relevant regulatory guidelines.
Exceptional communication and collaboration skills to work effectively in a matrixed environment.
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.
The annual base salary for this position ranges from $188,000 to $212,000. 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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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.
Alkermes Waltham, Massachusetts, USA Office
852 Winter Street, Waltham, MA 02451, US, Waltham, MA, United States, 02451
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