Director/Senior, Clinical Development
The Director/Senior, Clinical Development will provide scientific and technical expertise for assigned clinical programs and will bring experience in designing and conducting clinical trials. This position has primary responsibilities for setting strategy across the clinical development program, oversight of strategic study design, study start up, CRO and vendor management, clinical data and safety monitoring, analysis and reporting of studies.
What you'll do:
- Contribute as team leader and author in protocol development, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, interactions with US and Global Health Authorities
- Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, contributes to scientific publication of study results
- Serves as CD liaison/point-of-contact for inquiries from clinical operations, clinical research organizations (CROs), etc., collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
- Represents CD in sub-teams and addresses CD study or other program-specific questions, develops and provides input for clinical presentation slides and other materials for meetings and ongoing communication
- Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, health authorities, scientists and KOLs, as well as internal groups, including regulatory research, operations, legal and business development
- Participates in ongoing enhancements and development of team processes, structures, and tools
- Develops and mentors study team members
About you:
- MD, PhD or OD required; PharmD with relevant experience may be considered
- 5-10 years of clinical research and/or clinical development experience within the pharmaceutical or biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of fore mentioned.) Gene therapy and/or ophthalmology (retina) experience preferred.
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
- Diplomacy and positive influencing abilities
- Committed to developing and mentoring team
- Therapeutic area knowledge relevant to mechanism of action and retinal drug development
- Understanding of US and Global Regulatory requirements