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 Manager level Clinical Scientist role is a global role, based in our Philadelphia location. 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 Manager, Clinical Scientist will be responsible for regional or 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 may include leading cross-functional Study Conduct Teams, writing and/or reviewing protocols and other study related documents, country/site and vendor selection and start-up, study conduct and oversight, data review, and study close-out, for one or more clinical trials.The Manager, Clinical Scientist may be the lead Clinical Scientist on a trial or the regional Clinical Scientist supporting the Lead Clinical Scientist on a global trial. Is also a member of the Clinical Program Management function within Clinical Development Operations.KEY RESPONSIBILITIES
- Support study design, translate scientific imperative into operational delivery of trials. Contribute to 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 as study lead or regional support
- Plan and 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 or regionally.
- Contribute to Site/Investigator meetings and represent study team at industry conferences as needed.
- Provide guidance on protocol and procedures in the development of eCRFdesign
- Liaise with CRAs to identify trends on data management issues/lCF 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 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.
- Contribute to process improvement initiatives including SOP writing/revision, Guidance Documents, workstreams, etc.
QUALIFICATIONS & EXPERIENCE
Required
- Minimum of a BA/BS in Life Sciences Degree
- Previous experience working in a matrix environment
- 1-3+ years of industry-sponsored clinical trial management experience.
- Strong knowledge of clinical operations and the regulatory process -
- EDC experience including trial management, data review, issuing and resolving queries, CRF design/review/
- approval
- Experience with clinical protocol development and/or regulatory submissions and management
- Experience with biologics or cell and gene therapy or oncology
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.
