Job Summary:
- Plan and direct clinical research activities in ophthalmology for new or marketed medicines across the clinical development cycle (pre-clinical to post-licensure).
Responsibilities:
- Plan clinical trials (design and operational plans) based on development strategy.
- Provide medical oversight and overall conduct of ongoing/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 publications.
- 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 with cross-functional teams (commercialization, regulatory affairs, statistics, manufacturing) to manage clinical development projects.
- Keep colleagues informed of study progress (including competitor drugs) and provide internal/external expert scientific input.
- Maintain scientific knowledge by tracking developments, identifying strong investigators, building communications with clinical investigators, and attending scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global external collaborations.
- Travel ~25% to manage clinical research projects.
Education:
- M.D. or M.D./Ph.D.
Required Experience/Skills:
- Industry or academia faculty experience.
- 3+ years clinical medicine experience.
- 1+ year industry ophthalmology drug development OR academia biomedical research focused on ophthalmology.
- Demonstrated scientific scholarship; strong clinical medicine and biomedical research background.
- Strong interpersonal, verbal/written communication, and presentation skills.
Preferred:
- Board Certified or Eligible in ophthalmology (or related discipline).
- Prior clinical research experience and prior publication.