Medical Director Clinical Development Neurology
External job listingat Alkermes
Lead clinical development programs in neurology at Alkermes, with responsibilities spanning trial design, medical review, strategy, and external engagement.
Salary
Not provided
Location
Boston, United States
Employment type
Full time
Workplace
Not provided
Medical Director Clinical Development Neurology
Boston, United States
Job description
About the role
Alkermes is seeking a Medical Director for clinical development in neurology. This high-impact position has visibility across the organization and critical responsibilities in developing therapies for neurology and neuropsychiatric indications, including sleep disorders.
The role contributes to internal strategy on future therapeutic priorities and interacts with global regulatory authorities, industry and scientific organizations, and external key thought leaders. It works cross-functionally with partners across Alkermes.
Responsibilities
- Design and oversee execution of protocols across clinical research trials in neurologic disorders.
- Serve as the Global Clinical Lead for one or more programs, including leading their clinical subteams.
- Contribute directly to protocols, clinical study reports, study documents, regulatory documents, and external publications.
- Review clinical trial data and provide medical monitoring, in conjunction with a CRO medical monitor, for Phase 2 and Phase 3 clinical trials.
- Interact with senior management and serve as a standing member of one or more project teams.
- Contribute to strategic discussions about clinical development plans and indication prioritization.
- Represent Alkermes to external audiences, including clinical sites and industry partners.
- The role may include mentoring clinical research colleagues and clinical scientists.
Cross-functional partners include regulatory, preclinical research, clinical pharmacology, translational medicine, toxicology, CMC, new product planning, project management, patient engagement, health economics, legal, finance, medical affairs, and commercial.
Key facts
- The role involves clinical development for neurology and neuropsychiatric indications, including sleep disorders.
- Responsibilities include protocol design and execution across clinical research trials in neurologic disorders.
- The Medical Director provides medical review and monitoring for Phase 2 and Phase 3 clinical trials.
Frequently asked questions
What does the role involve?
The Medical Director contributes to clinical development of therapies for neurology and neuropsychiatric indications, including sleep disorders.
What are the clinical trial responsibilities?
Responsibilities include protocol design and execution, medical review of trial data, and medical monitoring of Phase 2 and Phase 3 trials.
Does the role involve external collaboration?
Yes. The role interacts with global regulatory authorities, industry and scientific organizations, thought leaders, clinical sites, and industry partners.