Study Physician - Immunology Cell Therapy

Here at AstraZeneca (AZ) you will have the chance to create a difference in patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines, answering medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.

AZ is seeking to appoint a Study Physician in Immunology Cell Therapy for the development of CAR-T cell therapies for autoimmune or inflammatory diseases. This is an excellent opportunity for an experienced and motivated drug developer to lead an innovative clinical stage cell therapy study.

The Study Physician will provide medical and scientific input to T-cell therapy clinical stage assets focused on rheumatology or clinical immunology.

They will take ownership for clinical development in cross-functional teams to support early to late phase clinical development activities. These include the creation of 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, all in close collaboration with relevant internal and external partners and clinical research organizations.

Experience in early and/or late-stage cell therapy drug development is highly desired, and preferably with rheumatology drug development experience (including diseases such as systemic lupus erythematosus, myositis, scleroderma, and other inflammatory diseases).

The successful candidate will thrive in a fast-paced, proactive can-do culture, be a highly effective internal and external team player as well as a strong communicator and collaborator.

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.

• Support the clinical development strategy from early target identification through late phase (with senior support as necessary) and secure cross-functional alignment across wider AZ organization.

• 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.

• Closely follow medical developments within the cell therapy autoimmune / inflammatory diseases and disseminate information within Clinical Development and the wider organization to transform trends and emerging data into innovative clinical plans.

• Support Immunology Cell Therapy Clinical Development at internal governance interactions and with external partners (as aligned with senior manager), including Investigators, key external authorities and patient advocacy groups (e.g., regulatory, site, CROs and KEEs).

• Contribute to regulatory communication and preparation of clinical sections of study and program level documents (e.g., protocols, ICFs, IB, briefing books, BTD, PIPs, SAPs, safety periodic reports).

• Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.

• May provide clinical strategic feedback to in-licensing opportunities.

Qualifications

• 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.

• Experience in rheumatology/clinical immunity is preferred.

• Significant experience in early and/or late phase clinical development, including hands-on experience in the design, delivery, and interpretation of multiple clinical studies.

• Significant experience in the authoring of relevant regulatory documents, including IND, protocols, ICF, IB, PIP, briefing books as well authoring responses to HA / EC.

• Thorough understanding of the full drug development process, including interpretation of non-clinical data and clinical study design and execution.

• Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with data-driven decisions.

• Knowledge of FDA, EMA, MHRA and ICH GCP guidelines to