Sr. Director - Clinical Operations Program Leader (COPL) - Ophthalmology
Related skills
vendor management edc etmf ctms ema📋 Description
- Lead ophthalmology clinical programs from early phase to pivotal trials.
- Develop and manage program timelines with data-driven planning.
- Maintain program status and communicate progress, risks, and mitigations.
- Drive feasibility, site/country selection, and resource allocation.
- Oversee trial operations end-to-end: protocol, start-up, enrollment, data, close-out.
- Ensure regulatory compliance (ICH-GCP, FDA, EMA) and audit readiness.
🎯 Requirements
- Bachelor’s degree in life sciences; advanced degree preferred (MS, PhD, PharmD, MD, NP, PA, or equivalent).
- 12+ years in clinical operations with ≥5 years in program leadership; global/multi-site experience; ophthalmology or cell therapy a plus.
- Direct management of clinical operations personnel.
- Deep knowledge of trial design and systems (CTMS, eTMF, EDC) and regulatory requirements (ICH-GCP, FDA, EMA).
- Proven CRO/vendor selection and management; strong PM, comms, and problem-solving; willing to travel up to 20%; early-phase experience.
- Experience in ophthalmology or rare disease/advanced therapy trials is highly desirable.
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