Vice President, Clinical Development
Orchard TherapeuticsLondon, England, United Kingdom • Boston, Massachusetts, United States
Posted August 29, 2025
Full Time
About the Company
Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on ending the devastation caused by genetic and other severe diseases by discovering, developing, and commercializing new treatments that tap into the curative potential of hematopoietic stem cell (HSC) gene therapy. In this approach, a patient’s own blood stem cells are genetically modified outside of the body and then reinserted, with the goal of correcting the underlying cause of disease with a single treatment. Founded in 2015, Orchard’s roots go back to some of the first research and clinical developments involving HSC gene therapy. Our team has played a central role in the evolution of this technology from a promising scientific idea to a potentially life-transforming reality. Today, Orchard is advancing a pipeline of HSC gene therapies designed to address serious diseases where the burden is immense for patients, families and society and current treatment options are limited or do not exist. For more information, please visit https://www.orchard-tx.com/.
Job Description
Orchard Therapeutics, a Kyowa Kirin company, is seeking a Vice President, Clinical Development to lead the Clinical Science organization. This role will oversee clinical development strategy, clinical studies, regulatory interactions, and regulatory documentations for the Orchard portfolio. The VP will serve as a key member of the Medical/Clinical Development team, collaborating with cross-functional teams and contributing to the preparation of regulatory filings. The position requires experience in leading matrix teams and managing clinical development programs.
Requirements
- At least 10 years experience in clinical development
- Highly desirable experience - ultra rare disease, gene therapy, paediatrics, neurometabolic disease, IBD
- Managerial experience
- In depth understanding of regulatory environment, GCP/ICH, experience interacting with regulatory agencies
- Proven track record of designing, leading, and executing clinical trials (Phases I–III)
- Desired experience – leadership of a regulatory file process (eg BLA, EU MAA, IND, CTA)
- Experience working with complex programmes, ideally experience in Gene/Cell Therapy programs
- Demonstrated ability to develop and execute clinical development strategies that align with broader corporate goals
- Desired experience – pharmacovigilance reporting, management, and operations
- Desired experience – US regulatory environment, US government affairs
- Excellent presentation and communication skills
- Flexible and solutions-driven
- Experienced in remote collaboration
- Experience overseeing global, multi-center trials
Benefits
- Competitive salary
- Opportunity for professional development
- Collaborative work environment
