- Responsible for the protocol design across all 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).
- Requires an MD with a Neurology background, Board Certified preferred with extensive clinical and academic experience in sleep medicine.
- At least five years of experience in the pharmaceutical industry.
- A business-focused individual, with experience in all aspects of drug development, including in-licensing. A person who has built on their medical expertise and successfully applied this to enhance the development and commercialization of new chemical entities (NCEs).
- Experience with successful NDA submissions and approvals and interactions with regulatory agencies are 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; 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.
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Executive Director, Clinical Development - Waltham, United States - Alkermes
Description
Position OverviewThis is a high impact position with great visibility across all levels of the Alkermes organization.
This position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for neurology indications, including sleep disorders.
The Executive 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
