Associate Director Clinical Scientist Immunology Cell Therapy

Are you a visionary expert in clinical drug development, possessing the capabilities to drive a successful strategy in accelerating the development of cellular therapies for patients with immune-mediated diseases? Are you dedicated to revolutionizing the treatment of immune-mediated diseases and creating a significant impact on patients' lives? Do you have a strong passion for science and substantial clinical development experience in Immunology and CAR-T cell therapies? Do you possess both strategic and operational leadership skills? If so, we invite you to join us! We are currently seeking an Associate Director Clinical Scientist, Immunology Cell Therapy to be based in Boston Seaport.

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases.

Immunology Cell Therapy

Our ambition is to build a world class organization that accelerates the delivery of transformative cell therapies for patients with immune mediated diseases. It’s our big vision that unites and inspires us. Cell therapies represent a fundamental evolution of how drugs are discovered, developed and manufactured; these new advanced, potentially curative cellular modalities require a new development strategy to ensure their rapid availability to patients. With multiple autoimmune and inflammatory indications and clinical stage cell therapies in global development, we keep pushing forward, focusing on cutting-edge science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity and collaboration – we make bold decisions driven by patient outcomes.

The Associate Director Clinical Scientist holds an expert position within the new and dynamic Immunology Cell Therapy organization at AstraZeneca and is a key member of the Global Project Team (GPT). Working under the supervision of a Clinical Lead/Study Physician or Senior Clinical Scientist, you will support—and over time increasingly lead—the medical and scientific aspects of early-phase clinical development for cell therapy programs across immune-mediated diseases. This is an exceptionally exciting and prestigious role, contributing significantly to AstraZeneca's global objectives and the value targets of our portfolio. You will partner closely with cross-functional teams at the enterprise level, including Oncology, Alexion, and several development partners, and act as the link between the GPT and externally sponsored collaborative research for your program. You will operate in compliance with GCP, AstraZeneca quality systems and relevant regulatory guidelines.

In collaboration with the clinical program leads you will be accountable for the clinical program strategy and clinical science delivery for early-phase, immunology cell therapy programs, including innovative approaches to delivery (e.g., new digital platforms and technology to ensure patient engagement, recruitment and retention). You will integrate knowledge of biology, translational hypotheses and biomarkers with clinical science, and you will plan, direct and deliver the clinical science components of assigned clinical programs from design concept to final CSR.

The accountabilities are broad; however, the core accountabilities are the medical & scientific support for the development and implementation of immunology cell therapy sponsored clinical program strategy and externally sponsored collaborative research (ESCR) program strategy and studies, including:

• Program level: Supporting clinical input to the Clinical Development Plan (CDP); preparing clinical and other data for governance and senior leadership presentations; contributing to recommendations to internal committees; supporting preparation and maintenance of program-level documents such as the Investigator’s Brochure (IB) and DSUR; monitoring and synthesizing developments in the scientific/medical literature and communicating implications to the team; ensuring scientific input to therapy‑area standard; collaborating with Lead Bio scientists and Translational Scientists to provide clinical input to pre‑CDID cell therapy products; supporting the development, review and quality of publications and publication strategy.
• Study level: Serving as the clinical science resource for assigned studies (and in some instances as the Study Clinical Lead); supporting/leading development of Clinical Study Protocols (CSPs), informed consent forms (ICFs), and electronic data capture (EDC) database specifications in line with the approved CDP and target product profile; supporting ongoing clinical data review and interpretation at study and program level with input from the study/program physician; contributing to development of quality metrics and data review plans for assigned studies; support and contribute to medical mon