Clinical Scientist-Associate Director
About the Team: Clinical Development Operations (CDO) lead the delivery of innovative, high-quality clinical development trials at Adaptimmune. In CDO we are committed to making cell therapy a viable option for all eligible patients. We are a highly effective, innovative and fast-moving team that’s open to change and new ideas. We work through a culture of cross-functional collaboration to deliver our clinical trials to plan, achieving high quality in everything we do. Everyone in CDO leads by example, where people are inspired to be the best they can be, being curious about new ways of working and being data-driven in decision-making.
MUST RESIDE IN THE SURROUNDING AREA, COMMUTABLE TO THE PHILADELPHIA SITE
PRIMARY RESPONSIBILITY
The Associate Director level Clinical Scientist role is a global role, based in either the US or the UK. The role provides scientific input and oversight, as well as leadership and management of cross-functional execution of clinical studies, within Adaptimmune’s programs.
The Clinical Scientist will be responsible for 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 writing and/or reviewing protocols, interacting with sites for feasibility assessment, site selection, start up, study conduct, data cleaning, data review, and study close-out, for one or more clinical trials.
KEY RESPONSIBILITIES
- Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, study plans, IP management plans, CSRs.
- Lead the cross-functional Study Conduct Team – drive operational delivery and facilitate issue resolution.
- Plan timelines, conduct study feasibility, risk assessment/management and contingency planning. Ensure timelines are communicated to all personnel assigned to the study (including vendors)
- Plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally.
- Provide guidance on protocol and procedures in the development of eCRF design.
- Review monitoring visit reports: liaise with monitors to understand any trends on data management issues/ICF issues/study binder issues/site staff issue to develop solutions.
- Review clinical trial data - monitor data quality and ensure appropriate quality measures are in place.
- Ensure consistency of study execution across studies to facilitate data analysis and regulatory filing.
- Study specific vendor interaction and coordination
- Liaise with clinical drug supply/manufacturing to ensure co-ordination for trial subjects.
- Maintain TMF and ensure inspection readiness.
- Proactive stakeholder management and communication of progress and issues
QUALIFICATIONS & EXPERIENCE
Required
- Minimum of a BA/BS in Life Sciences Degree
- Previous leadership in a matrix environment
- 7+ years of industry-sponsored clinical trial management experience required. Experience with biologics or cell and gene therapy is a plus.
- Strong knowledge of clinical operations and the regulatory process - experience independently running/managing multiple clinical trials preferably within the oncology area
- EDC including trial management, data review, issuing and resolving queries, CRF design/review/ approval.
- Prior experience with clinical protocol development and/or regulatory submissions and management
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.