Senior Medical Director, Clinical Development (Neurology)

Alkermes; Waltham (MA); Hybrid; USD 150,000 - 250,000; Full time

Job summary

An established industry player is seeking a Senior Medical Director to drive clinical development for innovative therapies in neurology and neuropsychiatry. This high-impact role involves leadership across clinical trials, strategic planning, and collaboration with regulatory bodies and thought leaders. The position offers a hybrid working model, allowing flexibility while ensuring a strong presence in the office. Join a company committed to making a meaningful impact on patients' lives through groundbreaking research and development, all while fostering a culture of diversity and inclusion. If you're passionate about advancing neuroscience, this opportunity is for you.

Benefits

Flexible working environment

Diversity and inclusion initiatives

Recognition as a Great Place to Work

Health and wellness programs

Qualifications

• MD required with experience in Psychiatry or Neurology.
• 4+ years in the pharmaceutical industry with drug development experience.

Responsibilities

• Lead protocol design and execution for clinical trials in neurologic disorders.
• Interact with regulatory authorities and key opinion leaders.

Skills

Leadership

Communication Skills

Clinical Development

Regulatory Interaction

Project Management

Collaboration

Detail-oriented

Education

MD in Psychiatry or Neurology

Board Certification in Neurology or Psychiatry

Job description

Job Description

This is a high impact position with great visibility and collaboration across multiple departments and all levels of the Alkermes organization. This position will have critical responsibilities in the clinical development group involved in the development of therapies for neurology and neuropsychiatric indications across early- and late-stage programs, contributing to Alkermes' expansion of Research and Development efforts in neuroscience.

Additionally, the Senior Medical Director will participate in internal strategy regarding future therapeutic priorities and modalities and interact extensively with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders.

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

• MD with experience in Psychiatry or Neurology required
• Board Certification in Neurology or Psychiatry preferred
• A minimum of four 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 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 navigate complexity and ambiguity in a highly matrixed work environment
• Demonstrated leadership and collaborative interpersonal skills, fostering teamwork and cross-functional partnerships
• Self-motivated with the ability to work independently, prioritize tasks efficiently, and meet deadlines
• Detail-oriented with expertise in conducting thorough and timely reviews of medical and trial related documents

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.

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

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.