Senior Scientist in Clinical Development

2 weeks ago


Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time
Our Company

Adaptimmune is a global biopharmaceutical company dedicated to developing cancer immunotherapies that harness the power of the body's immune system to fight cancer.

About the Role

We are seeking an experienced Clinical Operations Director to lead global clinical trial delivery, including planning, management, and reporting of trials in accordance with company plans/objectives, GCP, local country requirements, and company standard operating procedures. This includes leading cross-functional Study Conduct Teams, writing and/or reviewing protocols and other study-related documents, country/site selection, start-up, study conduct and oversight, data review, and close-out for one or more clinical trials.

Main Responsibilities
  • Study Design: Translate scientific imperative into operational delivery of trials. Review and/or write study concept, protocol, study plans, CSRs, publications.
  • Team Leadership: Lead cross-functional Study Conduct Teams, drive operational delivery, and facilitate issue resolution.
  • Timeline Planning: Conduct study feasibility, risk assessment/management, and contingency planning. Ensure timelines are communicated to all team members assigned to the study (including vendors).
  • Site Relationships: Develop relationships with clinical sites and KOLs globally.
  • Document Writing: Write and/or review protocols and other study-related documents.
  • Data Quality: Monitor data quality and ensure appropriate quality measures are in place to identify any issues with data metrics and data integrity.
  • Vendor Management: Interact and coordinate with cross-functional team members, as appropriate.
Requirements and Qualifications
  1. Minimum BA/BS in Life Sciences Degree.
  2. Experience leading cross-functional and cross-cultural teams in a matrix environment.
  3. Extensive industry-sponsored clinical trial management experience required, including biologics or cell and gene therapy in FIH, POC, and phase I/II studies.
  4. Strong knowledge of clinical operations and regulatory processes - experience independently leading multiple clinical trials within the oncology therapeutic area.
  5. EDC experience including trial management, data review, queries, CRF design/review/approval.
  6. Experience with clinical protocol development and/or regulatory submissions and management.


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