Full-Time

Clinical Trial Manager

Voyager Therapeutics

Voyager Therapeutics

51-200 employees

Develops gene therapies for neurological disorders

Biotechnology

Mid, Senior

Lexington, MA, USA

Required Skills
Communications
Requirements
  • Bachelor’s degree in a scientific/health care field preferred
  • Minimum of 5 years in clinical development in pharmaceutical/biotech industry
  • 2+ years of expertise in clinical trial management
  • Thorough knowledge of FDA and ICH GCP guidelines
  • Extensive experience managing complex protocols, CROs, 3rd party vendors, budgets, and timelines
  • Ability to travel up to 15% as needed
  • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
  • Strong communication skills and ability to work with and lead cross-functional study teams
  • Ability to work independently and act with initiative to address issues
Responsibilities
  • Lead the cross-functional study team to design, develop, execute and deliver clinical studies
  • Participate in the evaluation, selection, and oversight of CROs and other external vendors
  • Anticipate, recognize and resolve issues; as necessary, act as primary point of contact and manage escalation of study related issues
  • Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, trial reports and ASRs/DSURs
  • Review and approve study-related plans generated by CROs and vendors
  • Ensure appropriate clinical trial documentation including the trial master file
  • Review monitoring reports to ensure quality and resolution of site-related issues
  • Engage with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Monitor progress of clinical study activities and report on the progress of assigned clinical trials including budget and timelines
  • Perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance as necessary
  • Participate in the preparation and review of SOPs and other clinical operations initiatives

Voyager Therapeutics stands out in the biotechnology industry for its pioneering work in gene therapy and neurology, particularly in overcoming delivery challenges that have historically limited the potential of these disciplines. The company's TRACER AAV capsid discovery platform, which has generated novel capsids with high target delivery and blood-brain barrier penetration, is not only advancing Voyager's own pipeline of preclinical programs in Parkinson's disease, Alzheimer's disease, and ALS, but also fueling partnerships with industry leaders like Pfizer, Novartis, and Neurocrine Biosciences. Voyager's commitment to diversity and collaboration further enhances its competitive edge, fostering an inclusive culture that values different perspectives and is dedicated to making discoveries that can change the course of medicine for patients.

Company Stage

IPO

Total Funding

$344M

Headquarters

Cambridge, Massachusetts

Founded

2014

Growth & Insights
Headcount

6 month growth

8%

1 year growth

39%

2 year growth

47%
INACTIVE