Clinical Operations Director

2 months ago

Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time
Job Summary

We are seeking a highly experienced Clinical Scientist to lead our global clinical trial delivery efforts. As a key member of our Clinical Development Operations team, you will provide scientific and operational input and oversight, as well as leadership and management of cross-functional execution of clinical trials within our programs.

The ideal candidate will have extensive industry-sponsored clinical trial management experience, including experience with biologics or cell and gene therapy in FIH, POC and phase I/II studies. You 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 standard operating procedures.

You will lead cross-functional Study Conduct Teams, write and/or review 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. Additionally, you will develop and maintain effective relationships with clinical sites and KOLs globally, lead Site/Investigator meetings, and represent the study team at industry conferences, as needed.

Key Responsibilities
  1. Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, study plans, CSRs, publications.
  2. Lead the cross-functional Study Conduct Team – drive operational delivery and facilitate issue resolution.
  3. Plan/maintain timelines, conduct study feasibility, risk assessment/management, and contingency planning. Ensure timelines are communicated to all team members assigned to the study (including vendors).
  4. Develop and maintain effective relationships with clinical sites and KOLs globally. Lead Site/Investigator meetings and represent the study team at industry conferences, as needed.
  5. Provide guidance on protocol and procedures in the development of eCRF design.
  6. Liaise with CRAs to identify any trends on data management issues/ICF issues/quality issues/investigator site file (ISF) issues/site staff issues to develop solutions.
  7. Review clinical trial data; monitor data quality and ensure appropriate quality measures are in place to identify any issues with data metrics and data integrity.
  8. Support and review of study and site budgets, including vendors contracts, POs, and invoice approval.
  9. Study-specific vendor oversight, interaction, and coordination in conjunction with cross-functional team members, as appropriate.
  10. Liaise with treatment operations, logistics, and manufacturing teams to ensure subject treatment coordination.
  11. Ensure cross-functional maintenance of TMF and inspection readiness activities are completed.
  12. Proactive stakeholder management and communication of progress, risks, and issues.
  13. Line management responsibilities for Associate Director and Manager level Clinical Scientist; may provide mentoring of other members of CDO/company, as applicable.
  14. Contribute to process improvement initiatives, including SOP writing/revision, Guidance Documents, workstreams, etc.
Qualifications & Experience
Required
  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 experience with biologics or cell and gene therapy in FIH, POC, and phase I/II studies.
  4. Strong knowledge of clinical operations and the regulatory process – experience in independently leading multiple clinical trials, including 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.
  7. Experience writing scientific documents.
  8. Experience managing direct reports.
  9. Experience in taking pre-clinical to Clinical.
  10. Experience in early Development studies.
  11. Experience in Clinical Operations & Clinical Science.
Desirable
  1. Additional post-graduate scientific experience or qualifications, such as an MSc or PhD.

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