Senior Medical Director - Ophthalmology

We are seeking an experienced Senior Medical Director . In this pivotal role, you will contribute to shaping the global clinical development strategy and lead the management and execution of clinical trials across the ophthalmology space—from first-in-human studies through Phase 3—focused on innovative investigational products.

Key Responsibilities:

• Clinical Leadership: As Senior Medical Director, you will spearhead the clinical scientific strategy for Ophthalmology programs, overseeing clinical trial execution and ensuring alignment with the broader clinical development strategy.
• Study Protocol Development: Lead the creation of study protocol synopses, assess benefit/risk profiles, and validate protocols. Provide medical expertise during clinical feasibility and ensure the clinical operation teams are supported throughout the trial process.
• Operational Strategy: Drive the operational strategy for clinical studies, focusing on site selection, patient enrolment, feasibility, and resolving issues that may impact the quality and integrity of clinical trials.
• Stakeholder Engagement: Cultivate and maintain relationships with key opinion leaders (KOLs) and principal investigators (PIs), driving their input on emerging science, biomarker research, disease knowledge, and clinical study designs.
• Scientific Expertise: Stay at the forefront of scientific developments in ophthalmology, including in-depth knowledge of disease etiology, progression, diagnosis, and treatment. Regularly engage with scientific literature and attend conferences to maintain a strong reputation in the field.
• Competitive Landscape: Keep a pulse on regulatory and development issues related to competitive compounds and ensure our clinical program is well-positioned in the evolving market.
• Clinical Data Oversight: Lead medical reviews of trial data, ensuring continuous evaluation of safety, statistical outputs, and other trial data throughout study conduct, including safety monitoring and unmasked/masked data analysis.
• Trial Leadership: Act as Clinical Trial Lead, overseeing site interactions, training stakeholders, and addressing medical inquiries. Provide clinical education regarding disease areas, drug mechanisms, protocol requirements, and safety management.
• Safety Oversight: Oversee the evaluation of serious adverse events (SAEs) and ensure safety narratives are appropriately developed and reviewed.
• Regulatory & Compliance: Ensure compliance with Good Clinical Practice (GCP) and regulatory requirements, and maintain current training in these areas.
• Health Authority & Advisory Board Contributions: Serve as the medical point of contact in key regulatory interactions, advisory boards, and discussions.
• Clinical Documentation: Lead the creation of clinical content for clinical study reports (CSRs), regulatory submissions, briefing books, and other documentation required to support clinical trials and product development.

Qualifications: Skills and Experience:

• Managing and leading a cross-functional team, ensuring alignment with the overall medical strategy and timely execution of key initiatives.
• Medical Monitoring & Safety: Proven experience in medical monitoring, pharmacovigilance, and drug safety within a CRO, pharmaceutical, or clinical trial setting.
• Clinical Trial Expertise: A strong grasp of clinical trial design, methodologies, and regulatory requirements, with hands-on experience in ophthalmic clinical trials.
• Ophthalmology Knowledge: Solid understanding of ophthalmic diseases, treatments, and diagnostic techniques. Experience with ophthalmic imaging modalities (e.g., OCT, fundus photography) is highly desirable.
• Protocol Leadership: Prior experience in leading protocol development, including writing protocols and conducting protocol assessments.
• GCP & Ethics: Familiarity with Good Clinical Practice (GCP) guidelines and ethical principles governing human subject research.
• Retinal and Gene Therapy Trials: Experience in retinal clinical trials and phase 1/2 gene therapy studies is preferred.

Education and Experience:

• Educational Background: MD, MD/PhD, or PhD in life sciences, pharmacy, medicine, or a related field. Specialization in ophthalmology, particularly retina, with experience in retinal imaging, is a plus.
• Industry Experience: Significant experience in ophthalmology and translational drug development within the pharmaceutical or biotechnology sectors is preferred, with gene therapy experience a significant advantage.