Vice President, Clinical Development (Neurology)

Role Summary

The Vice President will drive Alkermes’s clinical development portfolio in Neurology with hands-on leadership responsibilities within the Clinical department. The role focuses on developing therapies for Neurology and Neuropsychology indications, including sleep disorders, neuropsychology, and neurodegenerative diseases. The position leads strategies and clinical plans across all phases of drug development, including study protocol development, medical review of trial data, and generation of clinical study reports, while interacting with global regulators, industry groups, and thought leaders. Collaboration across functions (Regulatory, Preclinical Pharmacology and Toxicology, CMC, New Product Planning, Project Management, Patient Engagement, Health Economics, Legal, Finance, Medical Affairs, and Commercial) is essential to coordinate projects with partners.

Responsibilities

• Primary leadership role for clinical development strategy and protocol design across all clinical trials in Neurology.
• Direct authorship contributions in protocols, clinical study reports, and publications.
• Lead and develop clinical development staff and oversee hiring as needed.
• Interact with senior management and participate in leadership meetings.
• Serve as a primary internal and external spokesperson for Alkermes Neurology clinical development programs.
• Represent the company to external audiences in clinical and pharmaceutical communities and organizations.
• Partner with cross-functional teams to assess external assets for strategic fit, scientific merit, and clinical viability, contributing to due diligence and portfolio expansion.
• Generate yearly strategic goals and objectives for the group.
• Oversee operational aspects of ongoing projects to meet time, cost, and quality expectations; coordinate budgets with clinical operations, project management, and finance staff.
• Ensure SOPs for Clinical Development facilitate effective study protocols and comply with industry standards.
• Develop collaborating relationships with investigators and thought leaders; oversee clinical advisory boards and investigator meetings.
• Contribute to regulatory interactions (INDs and NDAs).
• Oversee the professional development and management of the clinical sciences team.

Qualifications

• MD with a Neurology background and Board Certification, with significant clinical and academic expertise in Neurology.
• 10+ years of experience in the pharmaceutical industry.
• Business-focused with experience in all aspects of drug development, including in-licensing, applying medical expertise to development and commercialization of NCEs.
• Strong outcomes orientation, ability to operate in complex matrix structures, robust scientific insights, and excellent communication skills with internal and external audiences.
• Demonstrated leadership and collaborative interpersonal skills.
• Experience with NDA submissions and regulatory interactions is highly desirable.
• Ability to work independently, prioritize tasks, and meet deadlines; thorough review of medical and legal documents is expected.
• Excellent writing and presentation skills.
• Hybrid work model: role requires onsite presence at the Waltham, MA office at least 3 days per week; not eligible for fully remote work.

Additional Requirements

• Hybrid work arrangement requiring 60% in-office and 40% from home; onsite presence at least 3 days per week in Waltham, MA.