Senior/ Medical Director, Ophthalmology

The Company

AAVantgarde is a clinical-stage, international biotechnology company headquartered in Italy. We have developed two cutting-edge AAV vector platforms to overcome DNA cargo limitations, targeting Usher syndrome type 1B and Stargardt disease. Founded by the renowned Professor Alberto Auricchio, a pioneer in gene therapy, our mission is to transform genetic medicine for patients with no current therapeutic options. Join us at AAVantgarde and be a part of our innovative journey to bring the next generation of genetic medicines to those in need.

The Role

We are seeking an accomplished leader to join our team as (Senior) Medical Director. As a Medical Director, this individual will play a critical role in contributing to the global clinical development strategy, management and implementation of clinical studies from first-in-human trials through Phase 3 for assigned investigational products in Ophthalmology.

• The Senior Medical Director, Ophthalmology, will provide overall clinical scientific leadership for AAVantgarde Bio’s Ophthalmology programs and have responsibility for our clinical development strategy and execution of clinical trials in this area.
• Develop the study protocol synopsis, lead the analysis of benefit/risk for clinical development protocols and the final study protocol validation and protocol amendments; provide medical support to the clinical operation team during the clinical feasibility.
• Provide medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc., and serve as the primary point of escalation for issues identified which may affect the quality and integrity of clinical studies.
• Identify and build relationships with principal investigators (PI), key opinion leaders (KOL) in drug development. Identify and cultivate thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs.
• Maintain a strong medical/scientific reputation within the assigned disease areas. Have in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorders. Hold strong expertise in the disease areas by attending scientific conferences and ongoing review of the literature.
• Keep abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape.
• Lead medical data review of trial data, including eligibility review; ensure continuous medical review of aggregated data during clinical trial conduct (DSUR, medical safety, statistical outputs of unmasked/masked data).
• Serve as a Clinical Trial Lead, holding responsibility for site interactions such as medical questions and education (specific disease areas, drug mechanisms of action, protocol requirements, safety management guidelines, etc.). Provide clinical training for internal stakeholders and clinical trial sites.
• Hold responsibility for assessment of key safety-related serious adverse events and oversee safety narratives.
• Fulfill GCP and compliance obligations for clinical conduct and maintain all required training.
• Contribute to and serve as the medical point of expertise in key Health Authority interactions and advisory board meetings.
• Author/draft clinical content for CSRs, regulatory reports, briefing books, and submission documents to support closure, clinical narratives, reporting, and filling of the study.

Skills and Experience Required

The successful candidate will be an MD or MD/PhD or PhD (or equivalent) with an advanced degree in life sciences, pharmacy, medicine, or related field. A Medical Degree with specialization in ophthalmology (subspecialty training in retina and IRDs with retinal imaging experience) is desirable. You will also possess significant experience in Ophthalmology and translational drug development in the pharmaceutical or biotechnology industry; gene therapy experience will be a plus. Relevant work experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment is required, as well as a strong understanding of clinical trial design, methodology, and regulatory requirements. Knowledge of ophthalmic diseases, treatments, and diagnostic techniques is essential. You will ideally have experience with ophthalmic imaging modalities, such as OCT and fundus photography. Familiarity with Good Clinical Practice (GCP) guidelines and ethical principles governing human subjects research is a must. Experience in monitoring retinal trials and phase 1/2 gene therapy global trials is highly preferred.

What's in it for You

At AAVantgarde, we believe in creating an environment where our employees can thrive. Our flexible working environment allows you to balance work and life effectively. Our central London office, just a stone's throw from London Victoria train station, offers a prime location with top-notch facilities including a gym, coffee shop, and a rooftop garden. As a rapidly growing biotech with recent funding, there are ample opportunities for career advancement, and as we grow, so can you. We offer a generous salary, bonus, pension, health insurance through Vitality, and income protection, ensuring you have the support and resources you need to succeed. Join us and be part of an exciting, innovative journey in the world of biotechnology.

Equal Opportunities

At AAVantgarde, we are committed to fostering a welcoming, collaborative, and inclusive environment. We believe in providing equal opportunities for all and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected characteristics. All applicants will receive equal consideration for employment.