Sr. Medical Director

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May 24

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4D Molecular Therapeutics

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4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies. We have built a deep portfolio of genetic medicine product candidates, with five product candidates in clinical trials for seven patient populations.

51 - 200 employees

📋 Description

• The Senior Medical Director is accountable for the design, execution, and analysis of clinical trials in the Ophthalmology Therapeutic Area. • Provides clinical leadership to multidisciplinary study execution teams drawn from clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharm/tox, drug safety, commercial, and alliance partners. • Has lead accountability on the study teams for delivery of study protocols, study conduct, and study readouts. • Organizes and leads scientific advisory board meetings. Interacts with external experts and stakeholders to gather input. • Serves as medical monitor on clinical studies. • Serves as the primary clinical author of development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory submissions / correspondence, and project-related documents. • Works with the research organization and the portfolio management team to identify and support new project opportunities. • Collaborates to identify program risks, and to create and implement mitigation strategies. • Other duties as assigned.

🎯 Requirements

• Medical Degree (M.D.) • Residency training in Ophthalmology with a preference for subspecialty training in retina • Board certification a plus • Retina fellowship training a plus • 8+ years of clinical ophthalmology research in the biopharmaceutical industry • Experience with Phase 3 retina clinical trials • Experience with gene therapy a plus. • Experience in other phases (Phase 1, 2, 4) of clinical research a plus. • Experience with NDA/BLA/MAA submission a plus. • Experience writing clinical research protocols and acting as a medical monitor. • Experience in data analysis, data interpretation, and medical writing. • Knowledge of ICH-GCP and FDA regulatory guidelines. • Knowledge of international regulatory guidelines a plus. • Effective written and verbal communication skills, including public speaking

🏖️ Benefits

• Equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities