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Associate Director, Clinical Operations

Lexington, MA

About Voyager Therapeutics

Voyager 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.

Job Summary

Voyager Therapeutics is growing our clinical team and are seeking a strategic and tactical Associate Director of Clinical Operations to help advance the VY9323 SOD1 ALS program.  This role requires an individual who can balance hands-on execution of a complex clinical trial with high-level strategic thinking required to manage the clinical program.  The AD, Clinical Operations will be responsible for operational performance and ensuring assigned trial deliverables across programs are completed according to timelines, budget, procedures, quality standards, SOPs and business guidelines. Please note that this role requires the incumbent to work three (3) days per week at our Lexington office.  

Key Responsibilities

  • As Program Team member and Clinical Sub-team leader, provide operational expertise and strategic input to the development of Clinical Development Plans (CDP) supporting the overall clinical strategy for assigned clinical program(s).
  • Perform trial management activities for the First in Human gene therapy trial within assigned program.
  • Oversee selection of external vendors and manage vendor partnerships to secure deliverables within established timelines and financial investment
  • Review and approve study-related plans generated by CROs and vendors, and ensure the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies
  • Ensure appropriate clinical trial documentation including the trial master file.
  • Engage with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
  • Participate in the preparation and review of SOPs and other clinical operations initiatives.
  • Collaborate with cross-functional counterparts to oversee the performance for all activities assigned to our CROs and vendors, including escalation of issues when necessary.
  • Review and provide expert clinical operations input into clinical documents including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis and protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; may be responsible for the management of clinical document creation or updates.
  • Own and manage the clinical program budget and external spend related to clinical program execution; work closely with CROs and vendors, Program Management and Finance to ensure that budgets, enrollment, and forecasts are accurate.

Qualifications

  • Bachelor’s degree with minimum of 7 years of relevant experience in clinical operations or equivalent experience in the pharmaceutical/clinical research environment with cross-functional operational execution
  • In-depth understanding and working knowledge of ICH/GCP guidelines and FDA regulations and drug development processes
  • Prior management/supervisory experience and significant expertise in the oversight of clinical trials; sponsor experience preferred
  • Ability to work on problems of diverse scope and extremely complex in nature which may cross many functional areas
  • Previous experience working in gene therapy and/or neurodegenerative disorders is a plus
  • Proven ability to lead in a manner that creates a motivated, committed and engaged teams
  • Proven ability to communicate and function effectively across a matrix organization with multiple stakeholders
  • Demonstrated experience in successfully leading teams in an effective, efficient manner
  • Experience in developing global clinical development strategy and execution of these in multiple therapeutic areas
  • Strong operational excellence

 

 

 

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