Responsibilities:
- Lead clinical development strategy and protocol design across Neurology clinical research trials.
- Author/contribute to protocols, clinical study reports, and publications.
- Lead and develop clinical development staff; oversee hiring as needed.
- Interact with senior management; participate as a standing member of leadership meetings.
- Serve as primary internal and external spokesperson for Alkermes Neurology clinical development programs.
- Represent the company to external audiences in clinical/pharmaceutical communities.
- Partner with Business Development to assess external assets for strategic fit, scientific merit, clinical viability, due diligence, and portfolio expansion.
- Generate yearly strategic goals and objectives for the group.
- With clinical operations, oversee/coordinate operational aspects of projects to meet time, cost, and quality goals.
- With clinical operations, project management, and finance: generate study/departmental budgets and complete required administrative tasks.
- Ensure Clinical Development SOPs support effective, compliant protocols.
- Build relationships with investigators and global thought leaders; attend/oversee clinical advisory boards and investigator meetings.
- Critically review and contribute to regulatory interactions (e.g., INDs, NDAs).
- Oversee professional development and management of the clinical sciences team.
Qualifications:
- MD with Neurology background and Board Certification; significant clinical/academic expertise in Neurology.
- 10+ years of pharmaceutical industry experience.
- Business-focused drug development experience, including in-licensing; apply medical expertise to development and commercialization of NCEs.
- Strong outcomes focus; ability to work in complex matrix environments; strong scientific insight and communication skills.
- Strong leadership and collaborative interpersonal skills.
- Highly desired: experience with NDA submissions/approvals and regulatory agency interactions.
- Ability to work independently, prioritize, and meet timelines.
- Ability to perform thorough reviews of medical/legal documents in a timely manner.
- Excellent writing and presentation skills.
- Hybrid work: 60% office/40% home; onsite at Waltham, MA office at least 3 days per week; not fully remote.
Compensation/Benefits:
- Annual base salary range: $390,000β$423,000.
- Eligible for annual performance pay bonus.
- Competitive benefits package.