Job Description
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.