Senior/ Medical Director, Ophthalmology
London
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 Phase3 for assigned investigational products in the 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, leads the analysis of benefit/risk for clinical development protocols and the final study protocol validation and protocol amendments; Medical support to clinical operation team during the clinical feasibility.
- Provide medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrolment, feasibility, etc., and serve as primary point of escalation for issues identified which may affect quality and integrity of clinical studies.
- Identifies and builds relationships with principal investigators (PI), key opinion leaders (KOL) in drug development. Identifies and cultivates 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.
- Maintains a strong medical/scientific reputation within the assigned disease areas. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorders. Holds strong expertise in the disease areas by attending scientific conferences and ongoing review of the literature
- Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape.
- Leads 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, holds responsibility for site interactions such as medical questions and education (specific disease areas, drug mechanisms of action, protocol requirements, safety management guidelines etc.) Clinical training for internal stakeholders and clinical trial sites.
- Holds responsibility for assessment of key safety-related serious adverse events and oversees safety narratives.
- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training.
- Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings
- Authors/drafts 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. Medical Degree with specialisation 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 is preferred; 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 required as well as a strong understanding of clinical trial design, methodology, and regulatory requirements.
Knowledge of ophthalmic diseases, treatments, and diagnostic techniques. You will ideally have experience with ophthalmic imaging modalities, such as OCT and fundus photography. You must have familiarity with Good Clinical Practice (GCP) guidelines and ethical principles governing human subjects research.
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.
Recruitment Policy
AAVantgarde’s HR team leads all recruitment activities for AAVantgarde globally. AAVantgarde will not recognise any notional ownership recruitment companies claim to hold over candidates they present directly to hiring managers without the AAVantgarde HR team’s consent, nor any fees the recruitment company may feel are due as a result of this.Unsolicited resumes sent to AAVantgarde from recruiters do not constitute any type of relationship between the recruiter and AAVantgarde and do not obligate AAVantgarde to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring managers or employees.
If you are interested in becoming a recruitment partner please follow the instructions on the careers section of our company website.
London
Job Title: Freelance Medical Affairs Director - CNS (Central Nervous System)
Location: France (Remote)
About Us: We are a leading pharmaceutical company dedicated to pioneering therapies for Central Nervous System (CNS) disorders. Committed...
London
Job Summary :
We are seeking an Allergist - Medical Director to join our dynamic team. The Medical Director will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution...
ENGINEERINGUKLondon
and feedback of others.Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role.Effective negotiation, influencing and persuasion to enable others...