Study Physician, Medical Director - Neuroinflammation, Immunology Cell Therapy

Location: Office based role in Boston Seaport MA, USA

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 clinical development experience in Immunology/neroinflammation 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 a Study Physician - Immunology Cell Therapy, to be based in Boston Seaport.

About AstraZeneca

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. We are more than one of the world’s leading pharmaceutical companies.

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.

What You’ll Do

The Study Physician in Immunology Cell Therapy, Neuroinflammation holds an expert position within the new and dynamic immunology cell therapy organization at AstraZeneca. This is an exceptionally exciting and prestigious role, contributing significantly to AstraZeneca's global objectives and the value targets of our portfolio. As the Study Physician, they are responsible for contributing to CAR-T programs, beginning in multiple sclerosis and moving to other immune mediated diseases. This is an excellent opportunity for an experienced and motivated drug developer to lead an innovative clinical stage cell therapy study. Moreover, this role offers the unique opportunity to collaborate closely with cross-functional teams at the enterprise level, including Oncology, Alexion, and several development partners, thereby enhancing the overall impact and reach of the position. 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:

Provide expert medical and scientific input to cell therapy clinical stage assets in development for multiple sclerosis and additional immune-mediated diseases.

• 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 immune mediated 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,