Senior Clinical Research Director, Ophthalmology

Role Summary

Senior Clinical Research Director, Ophthalmology – Lead ophthalmology-focused clinical development for one or more indications within an R&D program, overseeing clinical teams to deliver successful trials for ophthalmologic diseases. Requires strong clinical leadership, strategic and operational capabilities, and ability to coordinate with internal and external stakeholders.

Responsibilities

• Provide ophthalmology focused medical and scientific expertise to the cross-functional project team to conduct clinical studies from early phases to lifecycle management programs
• Establish clinical development strategy and lead clinical team, collaborating with medical and clinical scientific experts, regulatory, statistics, safety, and other functional representatives to deliver development strategy and prepare/regulatory interactions
• Develop or contribute to regulatory documentation; provide clinical leadership for study start-up activities (e.g., pressure test, competitive intelligence, patient engagement, cluster feasibility, risk assessment)
• Provide medical input and clinical leadership for study conduct activities (IRB/HA responses, protocol training, data review, centralized monitoring, medical information for study team and investigators)
• Responsible for the clinical portion of regulatory documents (CTD) and responses to health authorities
• Serve as the medical expert in the Clinical Study team; mentor and train other clinical team members on medical/scientific strategy by indication

Scientific And Technical Expertise

• Deep scientific, technical, and clinical expertise in ophthalmology and retinal diseases
• Understanding of pre-clinical, clinical pharmacology, and data relevant to the molecule of interest
• Ability to critically evaluate medical literature and maintain credibility with internal and external stakeholders

Other Responsibilities

• Design global clinical development strategy and Clinical Development Plan; adjust strategy as project progresses
• Lead clinical development and lifecycle management (LCM)
• Monitor product benefit‚Äìrisk profile in development and LCM in collaboration with pharmacovigilance and clinical operations
• Identify, monitor, and resolve clinical program/trial issues
• Medical monitoring for a study or program and data review
• Provide medical input for feasibility, training, data review, and communications for study team and stakeholders
• Prepare/review key clinical documents (regulatory meeting requests, protocol, Investigator Brochure, CTD summaries)
• Contribute to SAP, TPP, and Risk Management Plans; respond to health authorities and IRB/Ethics committees
• Review clinical study reports, publications, and communications
• Lead medical/clinical assessment of license-in opportunities; manage other study physicians and clinical scientists
• Author or co-author manuscripts and abstracts; establish relationships with key opinion leaders/advisory boards
• Represent the clinical team at global project teams, regulatory meetings, steering committees, and submission task forces

About You

Basic Qualifications

• Medical Doctor (MD) with ophthalmology residency; fellowship training highly preferred
• Minimum 5 years of clinical trial and/or clinical development experience
• Fluent in English (verbal and written)

Preferred Qualifications

• Board certified or eligible in Ophthalmology
• Strong scientific/academic background with deep understanding of retina and eye diseases
• Clinical trial or pharmaceutical experience in ophthalmology
• Knowledge of drug development, ocular gene therapy, regulatory strategy
• Strong networking ability in cross-cultural environments
• Excellent interpersonal, communication, presentation, and negotiation skills
• Goal-oriented with ability to work within timelines and focus on strategy and execution
• Outstanding communicator with problem-solving, conflict-resolution, and decision-making skills