Senior Manager, Clinical Development

Orchard Therapeutics; City of Westminster; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading biotechnology company seeks a Senior Manager in Clinical Development to oversee clinical trials, ensuring regulatory compliance and high-quality data delivery. The ideal candidate is a physician with clinical experience in trial settings, excellent communication skills, and the ability to lead cross-functional teams. Key responsibilities include designing clinical strategies, maintaining study integrity, and collaborating with various stakeholders. This role is vital for developing innovative gene therapy solutions for rare diseases.

Qualifications

• Medical degree essential, with at least 4 years of clinical work following qualification.
• Understanding of regulatory environment, GCP/ICH.
• Proven experience in cross-functional working and collaboration.

Responsibilities

• Lead medical oversight and input to clinical trial design and conduct.
• Develop and execute clinical strategies and plans.
• Collaborate cross-functionally for study integrity and subject safety.

Skills

Scientific curiosity and analytical mindset

Strong communication skills

Leadership skills

Excellent organizational skills

Data interpretation and critical analysis

Education

Medical degree

Post-graduate qualification (e.g., MRCP, MRCS, MFPM, MD, PhD)

Job description

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. They will 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.

Responsibilities

• 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.
• Maintain close communication and collaboration with clinical sites and physicians, gaining insight into study design, identifying, and leading solutions for study issues.
• Lead and ensure 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).
• 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 or 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.
• Work cross-functionally to maintain a critical overview of study-related activities including SAE/stopping criteria, signal detection, data management/stats analysis, and planning investigators meetings, kick-off meetings, and similar forums for study activity discussions.
• Contribute to the development and maintenance of the clinical sciences budget for associated assets/activities, ensuring cost effectiveness and addressing and escalating issues as appropriate.
• Interact with various vendors in support of clinical development programs.
• Participate in publication plans and execution, as required.
• Ensure accurate maintenance and archiving of study records.
• Support the development of clinical development project plans, management of risk, monitoring of progress, and implementation of contingencies as required. Support the efficient use of resources and adherence to strategic initiatives.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
• Participate in business development initiatives for new programmes, as required.
• Presentations at internal and external meetings, congresses as required.

Profile and Experience

• The position will suit a physician newly moving into the pharmaceutical industry, with prior CRO or clinical trial experience, or with a number of years of experience within a sponsor company.
• Understanding of stages of clinical development, and fundamentals of data interpretation from clinical studies.
• Proven experience in cross-functional working, problem solving, and collaboration at the academia/CRO/sponsor interface.
• Collaborating with external partners, including investigators, academic partners, and vendors.
• Understanding of regulatory environment, GCP/ICH.
• Gene therapy / paediatrics / neurometabolic diseases / neurology / rare disease background desired.
• Medical degree essential, with at least 4 years of clinical work following qualification. Ideally with a relevant post-graduate qualification (e.g., MRCP, MRCS, MFPM, MD, PhD).

Skills

• Scientific curiosity and analytical mindset, strong attention to detail and documentation, strong ethical judgment and patient focus.
• Mature thinker, who takes accountability and is capable of working independently to make robust decisions, with awareness of when and how to escalate topics for senior input when needed.
• Strong communication (written and verbal) and presentation skills (including PowerPoint proficiency), enabling efficient sharing of information in external, internal, group, and 1:1 settings and the ability to respond to questions in real time with clarity and composure.
• A high achiever with the ability and desire to work in a fast-paced and highly dynamic environment. Can-do attitude and willingness to be flexible at short notice and adjust according to changing demands.
• Proactivity - pragmatic identification of issues, taking ownership of routes to solution without prompting.
• Strong leadership skills - able to lead workstreams and influence across cross-functional teams.
• Collaborative working style; partner effectively with colleagues across the organization to seek critical information, constructively challenge plans and assist with optimal allocation of resources.
• Excellent organisational skills: able to prioritize activities depending on business imperative and to contribute to multiple projects in parallel.
• Able to work and navigate the complexities of academic/biotech interface.
• Able to work in a virtual enterprise.
• Data interpretation and critical analysis skills.

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 U.S. headquarters in Boston and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.