Job Summary
Clinical Director (Principal Scientist) plans and directs clinical research activities in ophthalmology for new or marketed medicines across all phases of development.
Job Responsibilities
- Plan clinical trials based on the clinical development strategy (including operational plans)
- Provide medical oversight and ensure conduct of ongoing or new clinical trials for investigational or marketed drugs
- Analyze and summarize clinical findings to support safety/efficacy decisions and support regulatory filings, 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
The Clinical Director May
- Engage with cross-functional functional areas to support study execution
- Work with experts across commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
- Keep colleagues informed on progress of company and competitor drug studies
- Provide expert internal/external scientific opinions within scope
Scientific/Competency Activities
- Maintain awareness of scientific developments and research methodologies
- Identify strong investigators and establish communications with prominent clinical investigators
- Attend appropriate scientific meetings
- Author development documents, presentations, budgets, and position papers; facilitate global external collaborations
- Travel about 25% to manage future or ongoing clinical research projects
Education
- M.D. or M.D./Ph.D.
Required Experience and Skills
- Industry or faculty (academia) experience
- 3+ years clinical medicine experience
- 1+ year industry experience in ophthalmology drug development or biomedical research in ophthalmology academia
- Demonstrated scientific scholarship; proven clinical medicine and biomedical research background
- Strong interpersonal, teamwork, and communication/presentation skills
Preferred Experience and Skills
- Board Certified or Eligible in ophthalmology (or related discipline)
- Prior clinical research experience and prior publication