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Director, Clinical Research Scientist (Neurology)

Alkermes
19 days ago
Remote friendly (Greater Boston)
United States
Clinical Research and Development
This position reports to the Vice President, Clinical Development – Neurology and plays a pivotal role in the design, execution, and oversight of clinical trials, contributing to strategic regulatory interactions, clinical research strategies, and 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 development of clinical study protocols aligned with strategic objectives and regulatory requirements
- Assist with defining subject inclusion/exclusion criteria, research endpoints, and study methodologies
- Oversee selection and validation of clinical outcome measures and data collection methods
- Conduct 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 creation and execution of clinical development plans (Phase 1–3)
- Research new indications for a given molecule
- Provide clinical and scientific expertise for FDA communications
- Track competitor activities and advancements in neurology/CNS and translate into recommendations
- Contribute to scientific publications (abstracts, manuscripts, conference presentations)
- Establish and maintain relationships with KOLs, clinical investigators, and external experts
- Collaborate cross-functionally with Research, Regulatory Affairs, Medical Affairs, Business Development, and New Product Planning

Qualifications:
- Ph.D. or Pharm.D. in a relevant neurosciences field (neurology, neuropsychology, or related)
- 5+ years of pharma/biotech clinical research experience with trial design and execution
- Strong expertise in neurology and CNS disorders
- Proven track record leading clinical research initiatives and strategic development plans
- Experience with clinical investigators and key medical experts
- Expertise in clinical data analysis, interpretation, and application to trial design
- Strong knowledge of ICH, GCP, and relevant regulatory guidelines
- Demonstrated ability to publish in peer-reviewed journals
- Exceptional leadership, communication, and collaboration skills in a matrixed environment