Executive Medical Director, Clinical Development (Psychiatry)

Alkermes; Massachusetts; Hybrid; USD 360,000 - 390,000; Full time

Job summary

Alkermes in Waltham, MA is seeking an Executive Medical Director to lead clinical development in neuropsychiatric indications. The role drives protocol design, medical reviews, and strategic planning across programs, with cross-functional collaboration and external engagement.

The position requires an MD with psychiatry drug development experience and 7+ years in pharma, with strong leadership and regulatory interaction capabilities. Hybrid work is expected, onsite at least 3 days/week.

Qualifications

• MD with drug development experience in psychiatry.
• 7+ years in pharmaceutical industry with a focus on psychiatry/neuropsychiatry.
• Experience interacting with global regulatory agencies and NDA/BLA submissions.
• Strong written and verbal communication with senior management and external audiences.
• Ability to lead in a highly matrixed environment and manage complexity.

Responsibilities

• Design and execute protocols across neuropsychiatric clinical trials.
• Serve as Global Clinical Lead for programs and lead clinical subteams.
• Provide oversight of Phase 2/3 psychiatric programs and medical monitoring.
• Contribute to regulatory documents and external publications.
• Mentor junior clinical staff and interact with external stakeholders.
• Oversee operational aspects of projects to meet time, cost, and quality targets.
• Develop relationships with investigators and thought leaders; attend advisory boards and conferences.

Skills

Leadership

Medical expertise

Drug development

Regulatory interactions

Communication skills

Cross-functional collaboration

Travel readiness

Education

MD with psychiatry drug development

Job description

Job Description

This is a high impact position with great visibility across all levels of the Alkermes organization.

This position will have critical responsibilities in the clinical department involved in the development of therapies for neuropsychiatric indications. Key trial related responsibilities include development of study protocols, medical review of clinical trial data and generation of clinical study reports. Additionally, the Executive Medical Director will participate in internal strategy regarding future therapeutic priorities and interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key 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
• Serves as the Global Clinical Lead for 1 or more programs, including leadership of the clinical subteams of those programs
• Provide oversight of all ALKS programs being developed (Phase 2 and phase 3) in psychiatric indications
• 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 team(s)
• Contribute to strategic discussions related to clinical development plans and indication prioritization
• Mentor more junior clinical research colleagues and/or clinical scientists
• Represent the company to external audiences, including clinical sites, industry partners, 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 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)
• Depending on level, may participate in business development activities

Qualifications

• Requires an MD with drug development experience in psychiatry
• At least 7+ years of pharmaceutical industry experience, with a strong focus on psychiatry and neuropsychiatry, including direct experience in psychiatric drug development
• A business-focused individual, with experience in all aspects of drug development across early and late stage clinical programs
• A person who has built on their medical expertise and successfully applied this to enhance the development of new chemical entities (NCEs)
• Experience interacting with global regulatory agencies, including successful NDA or BLA submissions and approvals, is highly desired
• Outstanding written and verbal communication, with experience interacting with and presenting to senior management and external audiences
• Ability to manage complexity and ambiguity in a highly matrixed work environment
• Displays strong 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

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

The annual base salary for this position ranges from $360,000 to $390,000. In addition, this 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. Additional details can be found on our careers website: www.alkermes.com/careers#working-here

About Us

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

Why join Team Alkermes?

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because 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.