Third Rock Ventures - Lexington, MA
posted 4 days ago
About the position
Voyager Therapeutics is seeking an outstanding neurologist with neuromuscular expertise to join our growing Development team as Medical/Senior Medical Director. The Medical/Senior 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.
Responsibilities
- Contribute 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 indications.
- Serve as a medical expert in the company, staying current with the latest research and medical advancements in the fields being studied.
- Contribute 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 guidelines.
- Collaborate 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 brochures.
- Provide medical oversight for future clinical trials, including safety monitoring, data analysis, and interpretation of clinical trial results.
- Build and maintain strong relationships with key opinion leaders (KOLs) and academic institutions to support the company's scientific and clinical objectives.
- Collaborate closely with other departments such as clinical operations, technical operations/CMC, translational research and regulatory affairs to ensure alignment on program objectives.
- Lead the development of scientific publications, presentations, and educational materials related to Voyager's programs.
Requirements
- M.D. with deep Neuroscience experience
- 3+ years' experience in clinical development within a biotech or pharmaceutical company
- Experience in neurology clinical development is required and experience in neuromuscular diseases and/or dementia is optimal
- Experience in gene therapy drug development, RNA, nucleotide, and/or gene editing experience considered a plus
- Experience working collaboratively within a multi-disciplinary team of colleagues and proven ability to interact with external experts and investigators
- Adaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and multi-task to thrive in a small company
- Experience in early-stage development programs
- Demonstrated command working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Self-starter who works with a sense of urgency and functions as a strong team player
- Effective 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 writing
- Integrity, honesty and highest ethical standards and a sense of personal accountability
Nice-to-haves
- Experience in neuromuscular diseases and/or dementia is optimal
- Experience in gene therapy drug development, RNA, nucleotide, and/or gene editing experience considered a plus
