Senior Medical Director

3 weeks ago

Lexington, Massachusetts, United States Voyager Therapeutics, Inc. Full time

Voyager Therapeutics, Inc. 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 TRACERTM 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.

We are seeking an outstanding neurologist with neuromuscular expertise to 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 Responsibilities:

  • Provide expert clinical advice, drawing on extensive clinical knowledge.
  • Provide feedback on clinical study data, reports, protocols, and development plans.
  • 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:

  • 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.
  • ~ Demonstrated command working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
  • ~ Marked proficiency in clinical/medical writing.

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