Senior Director, Clinical Science

Role Summary

Senior Director, Clinical Science responsible for facilitating successful advancement of ophthalmology gene therapy programs, supporting clinical and scientific aspects of assigned clinical programs.

Responsibilities

• Partner with cross-functional program team members and key R&D stakeholders to support the development of innovative study designs, clinical trial protocols and amendments, investigator brochures, and other documents required to conduct clinical trials
• Provide clinical support for clinical study conduct, including operational feasibility, data management, communication plans, safety and medical monitoring, preparation of meeting materials and study updates
• Provide scientific support and cleaning/querying of key safety and efficacy data for ongoing clinical trials throughout conduct
• Prepare and communicate clear overviews of trial results
• Identify issues related to study conduct and/or subject safety; provide preliminary assessments and recommendations and collaborate with the clinical team to develop solutions and ensure resolution
• Interact with internal and external stakeholders (study sites, vendors, KOLs, etc.) in support of program-level strategy as well as clinical trial objectives
• Act as recognized clinical expert for assigned programs
• Contribute to the preparation of medical and scientific data for publications, presentations, and study milestones
• Together with Medical Director of Ophthalmology, serve as a point of contact for the clinical operations personnel, clinical trial sites and CROs for clinical science questions
• Maintain knowledge of ICH-GCP and FDA IND, and external regulations and procedures
• Contribute to authoring clinical documents such as protocol synopsis, clinical study reports, IBs, ICFs, training documents, and other clinical documents
• Author pertinent clinical sections of regulatory filings, including preparation of routine correspondence and sections of INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, and other regulatory submissions
• Other duties as assigned

Qualifications

• Education: A./M.S. in a biological/health science field is required; OD, PhD, or PharmD preferred
• Experience: A./M.S. with 12+ years clinical science experience, or OD/PhD/PharmD with 8+ years of experience with 5+ years of drug development, preferably in ophthalmology/retinal disease; advanced experience in clinical trial design, implementation, regulatory document preparation and statistics; Phase 3 experience, retinal gene therapy experience, NDA/BLA/MAA submission experience
• Other Qualifications/Skills: Ability to interpret, analyze, and present clinical data; thorough understanding of the drug development process; broad understanding of functional areas of drug development; strong written and verbal communication; ability to manage multiple projects in a fast-paced environment; leadership and collaboration skills

Skills

• Clinical data interpretation and presentation
• Regulatory documentation and submissions
• Cross-functional collaboration
• Communication of complex scientific information
• Trial design and statistics understanding
• Project and stakeholder management

Education

• Required: A./M.S. in a biological/health science field
• Preferred: OD, PhD, or PharmD

Additional Requirements

• Travel: 10%
• Physical Requirements: Sedentary office work; occasional repetitive motions; environment not substantially exposed to adverse conditions