Medical Director, Clinical Development (Neurology)

Alkermes; Boston (MA); Hybrid; USD 286,000 - 310,000; Full time

Benefits offered by this job

Hybrid work arrangement

Competitive benefits

On-site in Waltham, MA

Job summary

Alkermes is seeking a Medical Director to lead clinical development in neurology and neuropsychiatric indications. The role includes protocol design, data review, and external representation with regulators, industry partners, and thought leaders.

The position requires an MD with Neurology board certification, strong leadership, and cross-functional collaboration. Hybrid workplace in MA with on-site requirements, plus a competitive benefits package.

Qualifications

• MD with board certification in Neurology.
• Minimum two years of pharmaceutical industry experience.
• Business-focused with experience across drug development.
• Experience interacting with global regulatory agencies and NDA/BLA submissions.
• Strong communication and leadership abilities.
• Ability to manage complexity in a matrixed environment.

Responsibilities

• Protocol design and execution across clinical trials in neurologic disorders.
• Global Clinical Lead for programs and lead clinical subteams.
• Direct authorship in protocols, study reports, regulatory documents.
• Medical review of trial data and monitoring with CRO.
• Interact with senior management and project teams.
• Oversee operational aspects with clinical operations to meet time/cost/quality.
• Contribute to regulatory interactions (INDs/NDAs).
• Potential mentorship of junior staff.
• Represent Alkermes to external audiences.

Skills

MD with Neurology board

Clinical development

Regulatory interactions

Leadership

Medical writing

Education

MD with Neurology board certification

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 neurology and neuropsychiatric indications, including sleep disorders. Key trial related responsibilities include development of study protocols, medical review of clinical trial data and generation of clinical study reports. Additionally, the 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 neurologic disorders
• Serves as the Global Clinical Lead for 1 or more 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 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
• May include mentoring of 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 board certification in Neurology
• A minimum of two 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.
• 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.

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 $286,000 to $310,000.

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

Why join Team Alkermes?

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.

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.