Senior Manager, Clinical Development

Location:

London, UK

Reporting to:
Director, Clinical Development

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative cell and gene therapies. Orchard has its global headquarters in London and its headquarters in Boston and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

The Senior Manager, Clinical Development will play a key role in shaping and driving one or more of Orchard’s clinical development programs, by supporting the clinical development lead for that program. They will support the development and execution of clinical strategies that align with the company’s scientific and regulatory goals. They will also support regulatory interactions across all phases of development, from early clinical trials to regulatory approval and ongoing post-marketing commitments.

This is a unique opportunity to join a dynamic, forward-thinking team committed to advancing innovative therapies that have the potential to transform patient lives. This role is ideal for a medically trained professional early in their career who is eager to gain hands-on experience in clinical drug development within a dynamic biotech environment.

• Support the development and execution of robust clinical plans that meet scientific objectives, align with regulatory requirements across all participating regions, and deliver high-quality data for timely asset delivery.
• Medical oversight and input to clinical trial design, conduct, and data interpretation, working closely with cross-functional teams—including clinical operations, regulatory affairs, pharmacovigilance, and biostatistics.
• Collaborate with clinical operations and pharmacovigilance to ensure study integrity and subject safety.
• Maintains close communication and collaboration with clinical sites and physicians, gaining insight into study design, identifying, and leading solutions for study issues.
• Leading and ensuring development, review, finalization and delivery of high-quality key clinical study documents, including protocol, IB, CSRs, committee charters, SOPs and other compliance documents, where required, to meet study timelines.
• Support the clinical lead in regulatory interactions – both written and verbal (meetings).
• Key author in the strategic writing and review of clinical sections of regulatory documents and regulatory interactions (INDs, CTA submissions, information requests).
• Act as the medical monitor for one orf more programs, overseeing CRO medical monitoring, and providing medical input and expertise, including collaboration with pharmacovigilance.
• Maintain up-to-date knowledge of the scientific literature, competitive landscape, and regulatory requirements within relevant therapeutic areas.
• Works cross-functionally to maintain critical overview of study related activities including SAE / stopping criteria, signal detection, data management / stats analysis, etc; as well as planning investigators meetings, kick off meetings, and similar forums for study activities discussions.
• Contributes to the development and maintenance of the clinical sciences budget for associated assets / activities, ensuring cost effectiveness and addressing and escalating issues as appropriate.
• Able to interact with various vendors in support of clinical development programs.
• Participates in publication plans and execution, as required.
• Ensures accurate maintenance and archiving of study records.
• Supports the development of clinical development project plans, management of risk, monitoring of progress, and implementation of contingencies as required. Supports the efficient use of resources and adherence to strategic initiatives.
• Ensures adherence to Good Clinical Practice and all applicable local and international regulations.
• Participates in business development initiatives for new programmes, as required.

Presentation at internal and external meetings, congresses as required.

• Understanding of stages of clinical development, and fundamentals of data interpretation from…