Medical Director

3 weeks ago


Lexington, United States Voyager Therapeutics, Inc. Full time

About Voyager TherapeuticsVoyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of - and ultimately cure - neurological diseases. Our pipeline includes programs for Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit www.voyagertherapeutics.com.Voyager Therapeutics® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc. Job SummaryVoyager Therapeutics is seeking an outstanding neurologist with neuromuscular expertise to join our growing Development team as Medical Director. The Medical Director will play a key role on cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted for the clinical development of our novel TRACER AAV capsid discovery platform programs in neurological diseases. The successful candidate will have direct medical responsibility for creating clinical development plans, designing clinical studies, writing protocols, providing CRO oversight and safety monitoring of Voyager's clinical programs. The Medical Director will contribute collaboratively toward the clinical aspects of research and early-stage development programs, providing insight into treatment indications, patient populations, study designs and overall development strategies. Key ResponsibilitiesContribute to the development and execution of comprehensive clinical development plans for Voyager's development programs. Offer expert clinical advice, drawing on extensive clinical knowledge. Provide feedback on clinical study data, reports, protocols, and development plans. Collaborate with early development research teams on clinical aspects and disease indicationsServe as a medical expert in the company, staying current with the latest research and medical advancements in the fields being studiedContribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents, ensuring they are conducted in compliance with regulatory standards and ethical guidelinesCollaborate with the regulatory team to prepare and submit regulatory documents to health authorities, including INDs, NDAs, and BLAs. Collaborate with study team to prepare and complete clinical study reports, investigator's brochuresProvide medical oversight for future clinical trials, including safety monitoring, data analysis, and interpretation of clinical trial resultsBuild and maintain strong relationships with key opinion leaders (KOLs) and academic institutions to support the company's scientific and clinical objectivesCollaborate closely with other departments such as clinical operations, technical operations/CMC, translational research and regulatory affairs to ensure alignment on program objectivesLead the development of scientific publications, presentations, and educational materials related to Voyager's programsQualificationsM.D. with deep Neuroscience experience3+ years' experience in clinical development within a biotech or pharmaceutical companyExperience in neurology clinical development is required and experience in neuromuscular diseases and/or dementia is optimalExperience in gene therapy drug development, RNA, nucleotide, and/or gene editing experience considered a plusExperience working collaboratively within a multi-disciplinary team of colleagues and proven ability to interact with external experts and investigatorsAdaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and multi-task to thrive in a small companyExperience in early-stage development programsDemonstrated command working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studiesSelf-starter who works with a sense of urgency and functions as a strong team playerPatient focused, passionate about science and excited about having fun while workingEffective oral and written communication skills are required, as are excellent interpersonal skills with demonstrated ability to work with a small growing team. Marked proficiency in clinical/medical writingIntegrity, honesty and highest ethical standards and a sense of personal accountability


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