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Sr. Medical Director/Medical Director, Clinical Development
1 month ago
Position Overview
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 indications, including sleep disorders. Key domains include development of study protocols, medical review of clinical trial data and generation of clinical study reports. The Sr. Medical Director/Medical Director will 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 the protocol design across clinical research trials in sleep disorders.
- Direct authorship contributions in protocols, clinical study reports, and publications.
- Interact with senior management and serve as a standing member of project team meetings.
- Represent the company to external audiences in the clinical and pharmaceutical industry communities and organizations.
- In collaboration with the 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 protocols 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 and investigator meetings.
- Critically review and contribute to regulatory interactions (such as INDs and NDAs).
Skills, Education and Experience
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.
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