Clinical Operations Director

1 month ago


Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time

Key Responsibilities

  • Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, study plans, CSRs, publications
  • Lead the cross-functional Study Conduct Team – drive operational delivery and facilitate issue resolution
  • 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)
  • Develop and maintain effective relationships with clinical sites and KOLs globally. Lead Site/Investigator meetings and represent study team at industry conferences, as needed.
  • Provide guidance on protocol and procedures in the development of eCRF design.
  • 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.
  • 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.
  • Support and review of study and site budgets, including vendors contracts, POs and invoice approval.
  • Study specific vendor oversight, interaction and coordination in conjunction with cross-functional team members, as appropriate.
  • Liaise with treatment operations, logistics and manufacturing teams to ensure subject treatment co-ordination
  • Ensure cross-functional maintenance of TMF and inspection readiness activities are completed.
  • Proactive stakeholder management and communication of progress, risks and issues.
  • Line management responsibilities for Associate Director and Manager level Clinical Scientist; may provide mentoring of other members of CDO/company, as applicable.
  • Contribute to process improvement initiatives including SOP writing/revision, Guidance Documents, workstreams, etc.

Qualifications & Experience

  • Minimum BA/BS in Life Sciences Degree
  • Experience leading cross-functional and cross-cultural teams in a matrix environment.
  • 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.
  • Strong knowledge of clinical operations and the regulatory process - experience in independently leading multiple clinical trials including within the oncology therapeutic area.
  • EDC experience including trial management, data review, queries, CRF design/review/approval.
  • Experience with clinical protocol development and/or regulatory submissions and management.
  • Experience writing scientific documents. Experience managing direct reports.
  • Experience in taking pre-clinical to Clinical
  • Experience in early Development studies
  • Experience in Clinical Operations & Clinical Science

Desirable

  • Additional post-graduate scientific experience or qualifications, such as an MSc. or PhD


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