Vice President, Clinical Development (Neurology)
Specifically, this position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for Neurology indications, including neurogenerative and sleep disorders. The Vice President will drive the strategies and clinical plans across all phases of drug development. Key domains include development of study protocols, medical review of clinical trial data and generation of clinical study reports. The Vice President 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 pharmacology and toxicology, CMC, new product planning, project management, patient engagement, health economics, legal, finance, medical affairs and commercial.
RESPONSIBILITIES
- Primary leadership role for clinical development strategy, protocol design across all clinical research trials in all projects across Neurology.
- Direct authorship contributions in protocols, clinical study reports, and publications.
- Lead and develop clinical development staff and oversee hiring of additional staff as needed.
- Interact with senior management and serve as a standing member of multiple leadership meetings.
- Serve as a primary internal and external spokesperson for Alkermes Neurology clinical development programs.
- Represent the company to external audiences in the clinical and pharmaceutical industry communities and organizations.
- Generate yearly strategic goals and objectives for the group.
- 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.
- In collaboration with clinical operations, project management and finance staff, generate study and departmental budgets; complete other administrative tasks as required.
- 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).
- Experience in overseeing the professional development and management of the clinical sciences team.
QUALIFICATIONS
- Requires a MD with a Neurology background and Board Certification, alongside significant clinical and academic expertise in the field of Neurology.
- Accomplished, experienced, pharmaceutical professional with 10+ years of experience in the 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 NCEs.
- Key strengths include focus on outcomes, ability to work in complex matrix structures, strong scientific insights, and strong communication skills with both internal and external audiences.
- Displays strong leadership and collaborative interpersonal skills.
- Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired.
- Able to work independently, prioritize tasks efficiently and meet expected time frames.
- Able to perform thorough reviews of various medical and legal documents in a timely manner.
- Excellent writing and presentation skills.
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.