Clinical Director (Principal Scientist) β Responsibilities:
- Strategically plan and direct clinical research for investigational Immunology compounds, with late-stage development oversight across the full clinical development cycle (indications selection; study design; initiation; execution; monitoring; analysis; regulatory filing; publication).
- Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug (IND) applications.
- Support business development assessments for external opportunities to grow the Immunology pipeline.
- Develop clinical development strategies and plan clinical trials (design, operational plans, settings).
- Monitor and manage ongoing or new clinical trials.
- Analyze and summarize clinical findings to inform safety/efficacy decisions, regulatory submissions, clinical study reports, and publication.
- Participate in internal and joint internal/external research teams relevant to new compound development.
- Supervise Clinical Scientists executing clinical studies.
- Partner cross-functionally (commercialization, regulatory affairs, statistics, manufacturing) to manage clinical development projects.
- Maintain scientific knowledge by tracking advances, identifying strong investigators, building external collaborations (e.g., rheumatology), and attending relevant scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global collaborations; travel ~20% to manage clinical projects.
Education:
- M.D., D.O., M.D./PhD, or D.O./PhD.
Required:
- 5+ years of clinical and/or development experience.
- Demonstrated scientific scholarship/achievement.
- Strong interpersonal skills and ability to work cross-functionally.
Preferred:
- Prior experience designing/executing Phase 2 or 3 trials in rheumatologic diseases.