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Medical Director
2 months ago
This is a high-impact position with great visibility across all levels of the Alkermes organization. The successful candidate will have critical responsibilities in the clinical department involved in the development of therapies for neurology indications, including sleep disorders.
Key Responsibilities- Develop and implement clinical research protocols for sleep disorders.
- Contribute to the development of 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.
- Oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost, and quality performance expectations are met.
- Ensure that standard operating procedures 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 thought leaders globally.
- Critically review and contribute to regulatory interactions, such as INDs and NDAs.
- Requires an MD with specialization in Neurology or Sleep Medicine, and extensive clinical and academic experience in Sleep Medicine.
- A minimum of two years of experience in the pharmaceutical industry for Medical Director or more than three years of experience in the pharmaceutical industry for Senior Medical Director.
- A business-focused individual with experience in all aspects of drug development, including in-licensing.
- Experience with successful NDA submissions and approvals and interactions with regulatory agencies is highly desired.
- Outstanding written and verbal communication skills, with experience interacting with and presenting to senior management and external audiences.
- Ability to manage complexity and ambiguity in a highly matrixed work environment; demonstrated business acumen.
- 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 legal documents in a timely manner.
Alkermes has adopted a hybrid working environment to support and meet the needs of employees. 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 office at least 3 days per week.
