Latest Career Opportunity for Doctors: Study Physician – Immunology Cell Therapy Job at AstraZeneca
Responsibilities:
- Clinical authority representative for the study team.
- Responsible for the design, delivery, and interpretation of clinical studies from phase 1 through pivotal, ensuring compliance with GCP.
- Lead ongoing review and monitoring of clinical data to ensure quality, data integrity, investigation of data trends, and safety, including SAE/SUSAR/protocol deviations and periodic review of emerging safety, efficacy, and PK and biomarker data internally and by SRC/DMCs.
- Provide clinical development / disease expertise to research, clinical pharmacology, translational medicine, regulatory, biostatistics, safety, cell therapy delivery team (including CMC), and commercial colleagues as part of a cross-functional team.
What You’ll Do:
- Provide medical and scientific input to T-cell therapy clinical stage assets focused on rheumatology or clinical immunology.
- Take ownership for clinical development in cross-functional teams to support early to late phase clinical development activities.
- Create overall clinical development plans and clinical study design, writing study concepts and protocols, key study and health authority documentation, medical monitoring and ensuring timely delivery of studies.
- An MD, or other equivalent degree from an accredited university or an MD or equivalent degree plus a PhD.
- 3 or more years of validated experience in clinical development.
- Experience in clinical development of T-cell therapy is helpful.
