Medical Director

Sr. Medical Director, Clinical Development (Psychiatry)

Waltham, MA, United States

Job Description

This is a high impact position with great visibility across all levels of the Alkermes organization. The role will have critical responsibilities in the clinical department involved in the development of therapies for neuropsychiatric indications. Key trial responsibilities include development of study protocols, medical review of clinical trial data, and generation of clinical study reports. The Senior Medical Director will also participate in internal strategy regarding future therapeutic priorities and interact externally with key global regulatory authorities, industry and scientific organizations, and external thought leaders. This position will work cross‑functionally to ensure projects are coordinated with partners from multiple departments within Alkermes, including regulatory, preclinical research, clinical pharmacology, translational medicine, toxicology, CMC, new product planning, project management, patient engagement, health economics, legal, finance, medical affairs, and commercial.

Responsibilities

Responsible for protocol design and execution across clinical research trials in neuropsychiatric disorders.

Serve as the Global Clinical Lead for one or more programs, including leadership of the clinical subteams of those programs.

Provide direct authorship contributions in protocols, clinical study reports, study documents, regulatory documents, and external publications.

Provide medical review of clinical trial data and medical monitoring (in conjunction with a CRO medical monitor) of 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 related to clinical development plans and indication prioritization.

Mentor junior clinical research colleagues and/or clinical scientists.

Represent the company to external audiences, including clinical sites, industry partners, and patient advocacy groups.

Collaborate with clinical operations to oversee and coordinate the operational aspects of ongoing projects, ensuring that goals of time, cost, and quality performance expectations are met.

Ensure that standard operating procedures 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 thought leaders globally; attend and oversee clinical advisory boards, investigator meetings, and present at major medical conferences.

Critically review and contribute to regulatory interactions (such as INDs and NDAs).

Depending on level, may participate in business development activities.

Qualifications

MD with drug development experience in psychiatry.

At least 5–7 years of experience in the pharmaceutical industry.

A business‑focused individual with experience in all aspects of drug development across early and late stage clinical programs.

Experience in applying medical expertise to enhance the development of new chemical entities (NCEs).

Experience interacting with global regulatory agencies, including successful NDA or BLA submissions and approvals.

Outstanding written and verbal communication skills, with experience presenting to senior management and external audiences.

Strong ability to manage complexity and ambiguity in a highly matrixed work environment.

Demonstrated leadership and collaborative interpersonal skills.

Ability to work independently, prioritize tasks efficiently, and meet expected time frames.

Ability to perform thorough reviews of various medical and trial‑related documents in a timely manner.

Domestic and international travel (approximately 25%) is required.

Hybrid working environment: 60 % time in the office and 40 % from home. Eligible for the hybrid workplace model, requiring work onsite at the Waltham, MA office at least three days per week. This role is not eligible for fully remote work.

The annual base salary ranges from $340,000 to $360,000. In addition, the position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.

Equal Employment Opportunity Statement

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee on the basis of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service, or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E‑Verify employer.