Medical Director, Clinical Development (Neurology)

Role Summary

Medical Director, Clinical Development (Neurology) is a high impact position with visibility across Alkermes. The role involves critical responsibilities in developing therapies for neurology and neuropsychiatric indications, including sleep disorders, with medical oversight of early- to late-stage trials and cross-functional collaboration. The position requires interaction with global regulatory authorities, industry peers, and thought leaders, and will contribute to internal strategic planning and external communications. Location: Waltham, MA; hybrid work model (onsite at least 3 days/week).

Responsibilities

• Responsible for protocol design and execution across both early- and late-stage clinical research trials in neurologic disorders
• Serve as the Global Clinical Lead for multiple programs, including leadership of the clinical subteams of those programs
• Direct authorship contributions in protocols, clinical study reports, study documents, regulatory documents, and external publications
• Provide medical oversight of clinical trial data and medical monitoring (in conjunction with a CRO medical monitoring team) of Phase 2 and Phase 3 clinical trials
• Interact frequently with senior management and serve as a standing member of one or more project team(s)
• Contribute to strategic discussions related to clinical development plans and indication as well as asset prioritization
• Represent the company to external audiences, including clinical sites, key opinion leaders, and patient advocacy groups
• In collaboration with clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met
• Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research programs and are compliant with clinical/medical and industry standards
• Identify and develop collaborative relationships with key investigators, and key thought leaders globally. Attend, plan, and oversee clinical advisory boards, investigator meetings, and attend and present at major medical conferences
• Critically review and contribute to regulatory interactions (such as INDs and NDAs)
• Participate in business development due diligence activities, as needed

Qualifications

• Required: MD with experience in Psychiatry or Neurology
• Preferred: Board Certification in Neurology or Psychiatry
• Required: A minimum of two years of experience in the pharmaceutical industry
• Required: A business-focused individual, with experience in all aspects of drug development across early and late stage clinical programs
• Required: A person who has built on their medical expertise and successfully applied this to enhance the development of new chemical entities (NCEs)
• Preferred: Experience interacting with global regulatory agencies, including successful NDA or BLA submissions and approvals
• Required: Outstanding written and verbal communication, with experience interacting with and presenting to senior management and external audiences
• Required: Ability to manage complexity and ambiguity in a highly matrixed work environment
• Required: Displays strong leadership and collaborative interpersonal skills
• Required: Ability to work independently, prioritize tasks efficiently, and meet expected time frames
• Required: Ability to perform thorough reviews of various medical and trial related documents in a timely manner