The Clinical Director (Principal Scientist) plans and directs clinical research activities in the Immunology therapeutic area across all phases of clinical development, managing the full cycle for assigned studies (design, initiation, execution, monitoring, analysis, regulatory reporting, and publication).
Role Responsibilities:
- Plan clinical trials based on clinical development strategy.
- Provide medical oversight and ensure conduct of ongoing/new clinical trials for investigational/marketed drugs.
- Analyze and summarize clinical findings to support safety/efficacy decisions, regulatory submissions, and publications.
- Participate in internal and joint internal/external research teams for new and marketed compounds.
- Support business development assessments of external opportunities.
- Engage cross-functionally (commercialization, regulatory affairs, statistics, manufacturing) to manage clinical development projects.
- Provide internal/external expert scientific opinion on relevant questions.
- Maintain scientific knowledge, identify strong investigators, establish investigator communications, and attend scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global collaborations.
- Travel about 20% for clinical research project management.
Education:
- M.D. or M.D./Ph.D.
Required Experience/Skills:
- Industry or senior faculty academia experience.
- 3+ years clinical medicine experience.
- 1+ year industry drug development or biomedical research experience in academia.
- Record of scientific scholarship; strong clinical medicine and biomedical research background.
- Strong interpersonal/team skills.
- Provide expert opinion internally/externally.
Preferred:
- Board Certified/Eligible in Rheumatology (or related).
- Prior clinical research experience and publication.