Director, Clinical Scientist

Primary Responsibility

The Director level Clinical Scientist role is a global role, 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 the 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. The Director, Clinical Scientist, is a member of the Clinical Program Management function within Clinical Development Operations and may have line management responsibilities.

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 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. Experience managing direct reports.
8. Experience in taking pre-clinical to Clinical.
9. Experience in early Development studies.
10. Experience in Clinical Operations & Clinical Science.

Desirable

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