Ophthalmology Clinical Development Director
3 weeks ago
About the Role
We are seeking an experienced Ophthalmology Clinical Development Director to lead our clinical programs across different diseases and supervise the clinical development team. This individual will be responsible for medical monitoring and oversight of assigned clinical programs, including monitoring of clinical studies, review & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.
Key Responsibilities
- Designing and Implementing Clinical Development Strategy: Design and implement clinical development strategy and clinical protocols to deliver high-quality clinical programs, from first-in-human trials through to full development.
- Therapeutic Area Lead: Serve as the therapeutic area lead of the ophthalmology clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics.
- Medical Leadership: Provide medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc., and serve as primary point of escalation for all issues identified which may affect the quality and integrity of clinical studies.
- Medical Monitoring: Conduct medical monitoring, coding, and data cleaning in collaboration with Clinical Operations.
- Clinical Study Reports: Ensure the medical integrity of clinical study reports and data interpretation/communication.
- Regulatory Submissions: Author or oversee authorship of clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory meetings including presentation at Advisory Committee Meetings.
Requirements
- MD, DO, or Foreign Equivalent: Required: MD, DO, or foreign equivalent, with clinical experience.
- Clinical Experience: 10+ years of management experience in ophthalmology clinical development.
- Pediatric Experience: Pediatric experience preferred.
- Gene Therapy Experience: Gene therapy experience preferred.
- Clinical Residency Training: Clinical residency training in ophthalmology.
- Experience with Retinal Diseases: Experience with retinal diseases.
- Global Experience: 10+ years of global experience in ophthalmology clinical development in pharmaceutical/biotech industry, across multiple phases of clinical research (Phase 1-3).
- Knowledge of ICH-GCP and FDA Regulatory Guidelines: Knowledge of ICH-GCP and FDA regulatory guidelines.
- Domestic and International Travel: Domestic and/or International travel required 20%.
About Us
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT that connects talented individuals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. We offer a competitive total-rewards package to all employees around the world, including flexible work arrangements, competitive compensation, stock options and RSU awards, Employee Stock Purchase Plan (ESPP), flexible vacation policy, generous paid holiday schedule, winter break, 401(k) plan with company match, medical, dental, and vision plans, company-provided Life and Accidental Death & Dismemberment (AD&D) insurance, short-term disability benefits, supplemental life insurance, flexible spending accounts, accident and hospital indemnity insurance, employee assistance program (EAP), mental health online digital resource, well-being reimbursement, paid leave benefits for new parents, and paid time off to volunteer. Salary Range: $320,000 - $384,667 per year.
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