Vice President, Clinical Development Lead

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Vice President, Clinical Development Lead

This position will provide leadership and direction for the pipeline of an assigned clinical development program. The successful candidate will be responsible for developing and implementing the overall clinical strategy. They will emphasize early clinical development of the asset and be credible within the clinical function, bringing a high level of leadership and accountability.

The ideal candidate be a highly innovative, collaborative, scientifically-grounded and accomplished Clinical Development physician with a flexible, hands-on and team-oriented style. The Clinical Development Lead will be be a critical partner to counterparts in Research, Early Development, Regulatory, Clinical Operations, Safety and other expertise areas. He/she will be the AVROBIO program Development spokesperson at external meetings, including regulatory interactions and scientific meetings.

Research and Development
Oct 1 2021
Key Responsibilities
  • Overall Clinical Development Strategy and Plan.
  • Lead clinical study teams, monitor overall study integrity, and review, interpret, and communicate accumulating data pertaining to safety and efficacy.
  • Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities.
  • Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
  • Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders
  • Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy
  • Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.
  • Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners
Minimum Requirements/ Qualifications
  • MD with a strong research background; Experience in Genetics and/or Rare Diseases is desirable
  • Minimum 10+ years of Clinical Development experience required.
  • Experience leading clinical development programs, and actively participating in regulatory interactions with global health authorities; prior NDA/BLA/MAA preferred.
  • Adaptable and able to effectively lead, collaborate and influence across a complex matrix organization.
  • Excellent written and verbal communication skills
  • Excited to work in a highly entrepreneurial biotech environment

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by our industry leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario.

AVROBIO, Inc is an EEO employer