Role Summary
The Senior Clinical Research Director (CRD) is an expert ophthalmology clinical lead responsible for guiding one or more indications within an R&D program. The role leads clinical teams to deliver successful trials for novel ophthalmologic therapeutics, providing strategic and operational leadership, cross-functional collaboration, and mentorship. Requires strong clinical expertise, leadership, emotional intelligence, and the ability to manage multiple ongoing tasks. Location: Morristown, NJ or Cambridge, MA.
Responsibilities
- Provide ophthalmology-focused medical and scientific expertise to cross-functional project teams for studies from early phases to lifecycle management (LCM).
- Establish clinical development strategy and lead the clinical team; collaborate with medical/scientific experts, regulatory, safety, statistics, and other functions to deliver development strategy and support regulatory interactions.
- Develop or contribute to regulatory documentation; provide clinical leadership for study start-up activities such as risk assessment, feasibility, and patient engagement.
- Provide medical input and leadership for study conduct, including responses to IRBs/ethics questions, protocol training, data review, and medical information for the study team and investigators.
- Prepare clinical documentation for regulatory submissions (CTD) and respond to health authority questions.
- Serve as medical expert in the Clinical Study team; mentor other team members and train on medical/scientific strategy by indication.
- Design global clinical development strategy and Clinical Development Plan; adjust strategy as project progresses.
- Lead clinical development and planned lifecycle management; monitor benefit–risk in collaboration with pharmacovigilance and clinical operations.
- Identify, monitor, and resolve clinical program/trial issues; provide medical monitoring and data review for studies.
- Provide medical input for feasibility, training, data review, and medical communications; prepare regulatory meeting materials and CTD summaries.
- Contribute to SAP, Target Product Profile (TPP), and Risk Management Plan; respond to Health Authority and IRB inquiries.
- Review key study documents, publications, and communications; lead medical assessment of license-in opportunities; manage other CRDs and clinical scientists as needed.
- Author or co-author manuscripts and abstracts; establish collaborations with key opinion leaders and advisory boards.
- Represent the clinical team at global project teams, regulatory meetings, steering committees, and submission task forces.
Qualifications
- Required: Medical Doctor (MD) with ophthalmology residency; fellowship preferred; minimum 5 years of clinical trial/clinical development experience; fluent in English.
- Preferred: Board certified or eligible in Ophthalmology; strong scientific/academic background with retina/eye disease expertise; ophthalmology-focused clinical trial or pharmaceutical experience; knowledge of drug development, ocular gene therapy, regulatory strategy; strong networking and cross-cultural communication skills; ability to work toward timelines with strategic execution; excellent problem-solving and decision-making abilities.
Skills
- Deep scientific, technical, and clinical expertise in ophthalmology and retinal diseases
- Ability to interpret pre-clinical and clinical pharmacology data; critical literature appraisal
- Medical leadership across cross-functional teams; regulatory and health authority engagement
- Excellent interpersonal, communication, presentation, and negotiation skills
Education
- MD with ophthalmology residency; fellowship training highly preferred