Study Physician, Neuroinflammation, Immunology Cell Therapy

Job Profile: Study Physician, 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/neuroinflammation 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, Neuroinflammation, 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. As 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 with 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, 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.

Essential Skills/Experience:

• An MD, or other equivalent degree from an accredited university or an MD or equivalent degree plus a PhD, with specialty or experience in the immunology therapeutic area ideally with cell therapy expertise.
• Postgraduate subspecialty training medical training/board certification in relevant field with a history of holding substantive clinical positions at attending/consultant level preferably at a major academic medical center
• Minimum of 3 or more of expertise & experience in both the clinical setting and the drug development process, specifically in designing clinical trials coupled with the appropriate regulatory insights.
• Experience as clinical trialist in Neuroinflammation ideally Multiple Sclerosis in with deep knowledge of the of the landscape especially in the United States with a proven ability to engage with key sites, external experts and patient partners
• Adaptive problem solving and learning and ability to navigate complex organizations and systems
• Ability to influence both high level internal and external stakeholders.
• Ability to frame clear & succinct messages and simplify complexity of decision making
• 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 ensure the appropriate conduct of global clinical studies in the United States, Europe, and rest of world.
• Attention to detail, aim to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
• Proven experience leading complex projects and working collaboratively with multiple team members regarding new strategies to ensure consistent communication.
• Demonstrated track record in delivering results.
• Proven ability to learn new information rapidly and effectively

Desirable Skills/Experience

• Experience of clinical/commercial interface
• Global external awareness within the therapeutic area and global regulatory environment
• Ability to travel nationally and internationally