Medical Director, Clinical Development (Neurology)
Alkermes
August 19, 2026
Remote friendly (Greater Boston)
United States
Clinical Research and Development
Responsibilities:
- Responsible for protocol design and execution across clinical research trials in neurologic disorders.
- Serve as Global Clinical Lead for 1+ programs, including leadership of clinical subteams.
- Contribute to authorship of protocols, clinical study reports, study/regulatory documents, and external publications.
- Provide medical review of clinical trial data and medical monitoring (with a CRO medical monitor) for Phase 2 and Phase 3 trials.
- Interact with senior management and serve as a standing member of project teams.
- Contribute to clinical development planning and indication prioritization strategy.
- May mentor more junior clinical research colleagues and/or clinical scientists.
- Represent the company externally to clinical sites, industry partners, and patient advocacy groups.
- Oversee and coordinate operational aspects of ongoing projects with clinical operations to meet time/cost/quality goals.
- Ensure Clinical Development SOPs support effective, compliant clinical research programs.
- Develop relationships with key investigators and global thought leaders; oversee clinical advisory boards, investigator meetings, and attend/present at major medical conferences.
- Critically review and contribute to regulatory interactions (INDs/NDAs).
- Depending on level, may participate in business development activities.
Qualifications:
- MD with board certification in Neurology.
- Minimum 2 years of pharmaceutical industry experience.
- Experience across early and late-stage drug development.
- Experience applying medical expertise to enhance development of new chemical entities (NCEs).
- Highly desired: experience with global regulatory agencies; successful NDA/BLA submissions and approvals.
- Strong written/verbal communication; experience presenting to senior management and external audiences.
- Ability to manage complexity/ambiguity in a highly matrixed environment.
- Strong leadership and collaborative skills.
- Ability to work independently, prioritize, and meet timeframes.
- Ability to perform timely, thorough reviews of medical/trial documents.
- Responsible for protocol design and execution across clinical research trials in neurologic disorders.
- Serve as Global Clinical Lead for 1+ programs, including leadership of clinical subteams.
- Contribute to authorship of protocols, clinical study reports, study/regulatory documents, and external publications.
- Provide medical review of clinical trial data and medical monitoring (with a CRO medical monitor) for Phase 2 and Phase 3 trials.
- Interact with senior management and serve as a standing member of project teams.
- Contribute to clinical development planning and indication prioritization strategy.
- May mentor more junior clinical research colleagues and/or clinical scientists.
- Represent the company externally to clinical sites, industry partners, and patient advocacy groups.
- Oversee and coordinate operational aspects of ongoing projects with clinical operations to meet time/cost/quality goals.
- Ensure Clinical Development SOPs support effective, compliant clinical research programs.
- Develop relationships with key investigators and global thought leaders; oversee clinical advisory boards, investigator meetings, and attend/present at major medical conferences.
- Critically review and contribute to regulatory interactions (INDs/NDAs).
- Depending on level, may participate in business development activities.
Qualifications:
- MD with board certification in Neurology.
- Minimum 2 years of pharmaceutical industry experience.
- Experience across early and late-stage drug development.
- Experience applying medical expertise to enhance development of new chemical entities (NCEs).
- Highly desired: experience with global regulatory agencies; successful NDA/BLA submissions and approvals.
- Strong written/verbal communication; experience presenting to senior management and external audiences.
- Ability to manage complexity/ambiguity in a highly matrixed environment.
- Strong leadership and collaborative skills.
- Ability to work independently, prioritize, and meet timeframes.
- Ability to perform timely, thorough reviews of medical/trial documents.