Alkermes
Medical Director, Clinical Development (Neurology)
Alkermes, Boston, Massachusetts, us, 02298
Medical Director, Clinical Development (Neurology)
Join to apply for the
Medical Director, Clinical Development (Neurology)
role at
Alkermes .
This is a high impact position with great visibility across all levels of the Alkermes organization. The role involves critical responsibilities in the clinical department, focusing on 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.
The Medical Director will participate in internal strategy regarding future therapeutic priorities, interact externally with key global regulatory authorities, industry and scientific organizations, and external thought leaders. The position works cross‑functionally with departments such as 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 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 of Phase 2 and Phase 3 trials.
Interact frequently with senior management and serve as a standing member of one or more project teams.
Contribute to strategic discussions related to clinical development plans, indication, and 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 meet time, cost, and quality expectations.
Ensure that SOPs for Clinical Development facilitate effective clinical research programs and comply with standards.
Identify and develop collaborative relationships with key investigators and thought leaders globally; attend, plan, and oversee advisory boards, investigator meetings, and 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 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.
Experience applying medical expertise to enhance 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; experience presenting to senior management and external audiences.
Ability to manage complexity and ambiguity in a matrixed work environment.
Strong leadership and collaborative interpersonal skills.
Ability to work independently, prioritize tasks efficiently, and meet expected time frames.
Ability to perform thorough reviews of medical and trial‑related documents in a timely manner.
Alkermes has recently adopted a hybrid working environment to support and meet employee needs. This role will operate in a flexible environment with 60% of time in the office and 40% from home. The position is eligible for the hybrid workplace model, requiring at least 3 days per week onsite at our Waltham, MA office. This role is not eligible for fully remote work.
About Us Alkermes applies its deep neuroscience expertise to develop medicines that help people with complex psychiatric and neurological disorders. A fully integrated, global biopharmaceutical company headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we pursue great science driven by deep compassion to make a real impact.
Why join Team Alkermes? Alkermes has a portfolio of proprietary commercial products and a pipeline of clinical candidates for various neurological disorders. We foster a culture of diversity, inclusion, and belonging, and have been recognized as an employer of choice and for workplace mental health.
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.
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Medical Director, Clinical Development (Neurology)
role at
Alkermes .
This is a high impact position with great visibility across all levels of the Alkermes organization. The role involves critical responsibilities in the clinical department, focusing on 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.
The Medical Director will participate in internal strategy regarding future therapeutic priorities, interact externally with key global regulatory authorities, industry and scientific organizations, and external thought leaders. The position works cross‑functionally with departments such as 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 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 of Phase 2 and Phase 3 trials.
Interact frequently with senior management and serve as a standing member of one or more project teams.
Contribute to strategic discussions related to clinical development plans, indication, and 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 meet time, cost, and quality expectations.
Ensure that SOPs for Clinical Development facilitate effective clinical research programs and comply with standards.
Identify and develop collaborative relationships with key investigators and thought leaders globally; attend, plan, and oversee advisory boards, investigator meetings, and 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 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.
Experience applying medical expertise to enhance 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; experience presenting to senior management and external audiences.
Ability to manage complexity and ambiguity in a matrixed work environment.
Strong leadership and collaborative interpersonal skills.
Ability to work independently, prioritize tasks efficiently, and meet expected time frames.
Ability to perform thorough reviews of medical and trial‑related documents in a timely manner.
Alkermes has recently adopted a hybrid working environment to support and meet employee needs. This role will operate in a flexible environment with 60% of time in the office and 40% from home. The position is eligible for the hybrid workplace model, requiring at least 3 days per week onsite at our Waltham, MA office. This role is not eligible for fully remote work.
About Us Alkermes applies its deep neuroscience expertise to develop medicines that help people with complex psychiatric and neurological disorders. A fully integrated, global biopharmaceutical company headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we pursue great science driven by deep compassion to make a real impact.
Why join Team Alkermes? Alkermes has a portfolio of proprietary commercial products and a pipeline of clinical candidates for various neurological disorders. We foster a culture of diversity, inclusion, and belonging, and have been recognized as an employer of choice and for workplace mental health.
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.
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