Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
Primary ResponsibilityThe Director level Clinical Scientist role is a global role, based in either the US or 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
- 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
Required
- 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
- Strong knowledge of clinical operations and the regulatory process - experience 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
Desirable
- Additional post-graduate scientific experience or qualifications, such as an M.Sc. or PhD
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
