Director, Clinical Scientist

Adaptimmune; Abingdon; On-site; GBP 70,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director of Clinical Science to manage global clinical trials in an innovative environment. This role demands extensive experience in conducting trials across various phases, with responsibilities including protocol development, data review, and team leadership. The ideal candidate will have a strong background in life sciences and regulatory processes, along with the ability to lead cross-functional teams effectively.

Qualifications

• Experience leading cross-functional teams in clinical settings.
• Strong knowledge in clinical operations and oncology trials.
• Proficient in scientific writing and protocol development.

Responsibilities

• Lead global clinical trial delivery and manage study timelines.
• Collaborate with cross-functional teams for trial execution.
• Oversee clinical data integrity and vendor management.

Skills

Clinical trial management

Regulatory processes

Data management

Education

BA/BS in Life Sciences

Post-graduate qualifications (MSc/PhD)

Tools

EDC systems

Job description

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Primary Responsibility

The Director level Clinical Scientist role is a global position based in the UK. The role provides scientific and operational input and oversight, as well as leadership and management of cross-functional execution of clinical trials within Adaptimmune’s programs.

The Director, Clinical Scientist, will be responsible for leading global clinical trial delivery, including planning, management, and reporting of trials in accordance with company plans/objectives, GCP, local country requirements, and company SOPs. This includes leading cross-functional Study Conduct Teams, writing and reviewing protocols and other study-related documents, site selection, study start-up, conduct, data review, and close-out for one or more clinical trials. The Director, Clinical Scientist, is part of the Clinical Program Management within Clinical Development Operations and may have line management responsibilities.

Key Responsibilities:

• Support study design, translating scientific imperatives into operational trial delivery. Review and/or write study concepts, protocols, study plans, CSRs, and publications.
• Lead the cross-functional Study Conduct Team, driving operational delivery and facilitating issue resolution.
• Plan and maintain timelines, conduct feasibility assessments, risk management, and contingency planning. Communicate timelines to all study team members, including vendors.
• Develop and maintain relationships with clinical sites and KOLs globally. Lead site/investigator meetings and represent the study team at industry conferences as needed.
• Provide guidance on protocol development and procedures, including eCRF design.
• Collaborate with CRAs to identify trends in data management, ICF, quality issues, and site files, developing solutions accordingly.
• Review clinical trial data, monitor quality, and ensure appropriate measures are in place to maintain data integrity.
• Support study and site budgets, including vendor contracts, POs, and invoice approvals.
• Oversee vendor interactions and coordination in conjunction with the cross-functional team.
• Coordinate with treatment operations, logistics, and manufacturing teams to ensure subject treatment coordination.
• Maintain TMF and inspection readiness activities.
• Manage stakeholders proactively, communicating progress, risks, and issues.
• Line management for Associate Directors and Managers, with potential mentoring responsibilities.
• Contribute to process improvement initiatives, including SOP revisions and guidance documents.

Qualifications & Experience

Required

• Minimum BA/BS in Life Sciences.
• Experience leading cross-functional and cross-cultural teams in a matrix environment.
• Extensive industry-sponsored clinical trial management experience, including biologics or cell and gene therapy in FIH, POC, and phase I/II studies.
• Strong knowledge of clinical operations and regulatory processes; experience leading multiple clinical trials, especially in oncology.
• Experience with EDC, including trial management, data review, queries, and CRF design/review/approval.
• Experience with clinical protocol development and regulatory submissions.
• Experience in writing scientific documents and managing direct reports.
• Experience transitioning from pre-clinical to clinical development.
• Experience in early development studies.
• Experience in Clinical Operations and Clinical Science.

Desirable

• Post-graduate scientific qualifications such as MSc or PhD.