We are currently seeking a Director, Clinical Research Scientist (CRS) to join our Clinical Development Group. This position will report to the Vice President, Clinical Development – Neurology and play a pivotal role in the design, execution, and oversight of clinical trials. The Director, CRS will be responsible for contributing to strategic regulatory interactions, developing clinical research strategies, and ensuring scientific integrity across clinical programs.

Responsibilities

• Lead clinical data review strategies across multiple development programs
• Manage DSMB activities across multiple trials across all stages of development
• Contribute to the development of clinical study protocols, ensuring alignment with strategic objectives and regulatory requirements.
• Assist with defining subject inclusion/exclusion criteria, research endpoints, and study 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.
• Present key clinical findings and recommendations to cross-functional teams and senior leadership.
• 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 clinical and scientific expertise for FDA communications.
• Stay abreast of competitor activities and advancements in neurology and CNS-related fields, translating insights into actionable recommendations.
• 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.
• Collaborate cross-functionally with Research, Regulatory Affairs, Medical Affairs, Business Development, and New Product Planning teams to ensure alignment with broader corporate objectives. 

Qualifications

• Advanced degree (Ph.D. or Pharm.D.) in a relevant neurosciences field (neurology, neuropsychology, or related discipline).
• Minimum of 5 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.
• Expertise in clinical data analysis, interpretation, and application to trial design.
• Strong knowledge of ICH, GCP and other relevant regulatory guidelines.
• Demonstrated ability to publish in peer-reviewed journals.
• Exceptional leadership, 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. 

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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.