VP, 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.

Job Summary

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.

Cambridge
Research and Development
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
About AVROBIO

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer