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Clinical Scientist-Associate Director Jobs
Company | Adaptimmune |
Address | Philadelphia, PA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-07-30 |
Posted at | 10 months ago |
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. 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.
- Review clinical trial data - monitor data quality and ensure appropriate quality measures are in place.
- Proactive stakeholder management and communication of progress and issues
- 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.
- Ensure consistency of study execution across studies to facilitate data analysis and regulatory filing.
- Study specific vendor interaction and coordination
- Provide guidance on protocol and procedures in the development of eCRF design.
- Plan timelines, conduct study feasibility, risk assessment/management and contingency planning. Ensure timelines are communicated to all personnel assigned to the study (including vendors)
- Maintain TMF and ensure inspection readiness.
- Plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally.
- Liaise with clinical drug supply/manufacturing to ensure co-ordination for trial subjects.
- 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.
- 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.
- 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
- Strong knowledge of clinical operations and the regulatory process - experience independently running/managing multiple clinical trials preferably within the oncology area
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