Responsibilities:
- Design and execute clinical research protocols for neuropsychiatric disorders.
- Serve as Global Clinical Lead for one or more programs, including leadership of clinical subteams.
- Contribute directly to protocols, clinical study reports, study documents, regulatory documents, and external publications.
- Provide medical review of clinical trial data and medical monitoring (with a CRO medical monitor) for Phase 2/3 trials.
- Interact with senior management; serve as a standing member of project teams.
- Support strategic discussions on clinical development plans and indication prioritization.
- Mentor junior clinical research colleagues and/or clinical scientists (may include).
- Represent the company to clinical sites, industry partners, and patient advocacy groups.
- Oversee and coordinate operational aspects of ongoing projects with clinical operations to meet time, cost, and quality goals.
- Ensure Clinical Development SOPs enable effective, compliant programs.
- Build relationships with key investigators and thought leaders; oversee clinical advisory boards/investigator meetings; present at major conferences.
- Critically review and contribute to regulatory interactions (e.g., INDs, NDAs).
- May participate in business development activities (depending on level).
Qualifications:
- MD with drug development experience in psychiatry.
- 5β7+ years in the pharmaceutical industry.
- Business-focused experience across early/late-stage drug development; experience enhancing development of new chemical entities (NCEs).
- Highly desired: experience with global regulatory agencies, including successful NDA/BLA submissions/approvals.
- Outstanding written/verbal communication; ability to present to senior management and external audiences.
- Ability to manage complexity/ambiguity in a matrix environment; strong leadership and collaboration.
- Ability to work independently, prioritize, and meet timelines; perform thorough timely document reviews.
- Travel ~25%.
Hybrid work: 60% office/40% home; onsite at Waltham, MA at least 3 days/week; not fully remote.
Compensation: $340,000β$360,000 base salary plus annual performance bonus; competitive benefits.