Job Summary
Clinical Director (Principal Scientist) plans and directs clinical research activities in ophthalmology for new or marketed medicines across the full development lifecycle (pre-clinical to post-licensure), including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
Responsibilities
- Plan clinical trials based on clinical development strategy.
- Provide medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs.
- Analyze and summarize clinical findings to support safety/efficacy decisions, new drug applications, clinical study reports, and publication.
- Participate in internal and joint internal/external research project teams for new compounds and further study of marketed compounds.
- Support business development assessments of external opportunities.
- Engage cross-functionally (commercialization, regulatory affairs, statistics, manufacturing) to manage clinical development projects; provide expert scientific input internally/externally.
- Maintain scientific knowledge; identify investigators; build collaborations; attend scientific meetings.
- Author development documents (presentations, budgets, position papers); facilitate global collaborations; travel ~25% to manage clinical research.
Education/Qualifications
- M.D. or M.D./Ph.D.
Required Experience/Skills
- Industry or faculty academia experience
- 3+ years clinical medicine; 1+ year ophthalmology drug development industry or ophthalmology-focused academic biomedical research
- Record of scientific scholarship; strong clinical and biomedical research background
- Strong interpersonal, verbal/written communication, and presentation skills
Preferred Experience/Skills
- Board Certified or Eligible in ophthalmology (or related)
- Prior clinical research experience and prior publication