Senior Director, Clinical Science

Role Summary

Senior Director, Clinical Science will play an integral role in facilitating successful advancement of ophthalmology gene therapy programs. The position supports clinical and scientific aspects of all assigned clinical programs. Reporting to the VP Clinical Science, this role will act as a clinical expert for assigned programs and collaborate across cross-functional teams to develop innovative study designs, clinical trial protocols, and regulatory documents while ensuring compliance with ICH-GCP and FDA IND requirements.

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
• Serve as a point of contact for clinical operations personnel, clinical trial sites and CROs for clinical science questions
• Maintain knowledge of ICH-GCP, 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 and structured communications for INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, and other 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 including 5+ years in drug development with ophthalmology experience (retinal disease preferred); 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 preclinical, regulatory, pharmacovigilance, drug supply, data sciences, and clinical operations; strong written and verbal communication; ability to synthesize literature and competitive intelligence to support development strategy; understanding of trial design and statistics; well-organized with ability to manage multiple projects in a fast-paced environment; leadership and collaboration skills

Skills

• Clinical data interpretation and presentation
• Strong written and verbal communication
• Cross-functional collaboration and leadership
• Strategic thinking to support robust clinical development plans
• Regulatory document preparation and submission experience

Education

• A./M.S. in a biological/health science field required
• OD, PhD, or PharmD preferred

Additional Requirements

• Travel: Up to 10%
• Physical Requirements: Sedentary work; occasional repetitive motions; ability to lift up to 10 pounds occasionally; typical office environment