Global Clinical Program Lead, Neuroinflammation, Immunology Cell Therapy

Job Profile: Global Clinical Physician Lead, 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 substantial 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 Global Clinical Program Lead, 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 Global Clinical Physician Lead, 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. Reporting directly to the Head of Immunology Cell Therapy in Boston, this person will also be a pivotal member of the leadership and clinical teams working in an adaptive matrixed environment. As the Global clinical Physician Lead, they will be responsible for spearheading the Neuroinflammation program with a focus on Multiple Sclerosis and related studies in immune-mediated diseases. 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 pre-clinical and clinical stage assets in development for neuroinflammatory diseases and additional immune-mediated diseases
• Accountable for clinical scientific aspects of the cell therapies in Neuroinflammatory indications, including the benefit/risk of a product and/or asset as well as the scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), Clinical components of regulatory documents, medical monitoring and ensuring timely delivery of studies.
• Lead Immunology Cell Therapy Clinical Development for neuroinflammation 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).
• 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 strategies
• Provide impactful medical strategy and cell therapy expertise to Research, Translational Medicine and Commercial Partners, including in the development of therapeutic area strategy
• Work closely and collaborate across early and late clinical development, partner functions and wider AZ organization in Oncology and Rare disease to ensure design and delivery of clinical development plans with high quality and speed

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 Neuroinflammation or related 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 5 or more years of expertise & experience in both the clinical setting and the drug development process, specifically in designing clinical trials coupled with the appropriate regulatory insights.
• Extensive as a clinical trialist in Neuroinflammation ideally Multiple Sclerosis 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
• Global external awareness within the therapeutic area and global regulatory environment
• 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
• Substantial experience in early and/or late phase clinical development, including hands-on experience in the design, delivery, and interpretation of multiple clinical studies.
• Thorough understanding of the full drug development process, including interpretation of non-clinical data and clinical study design and execution.
• Thorough command of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with data-driven decisions.
• Thorough command 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.
• Track record of leading successful high performing global cross-functional team as well as line management experience.
• Proven ability to learn new information rapidly and effectively, with excellent analytical, problem solving and strategic planning skills.

Desirable Skills/Experience:

• Experience in clinical development of CAR-T-cell therapy is highly desired.
• Experience of clinical/commercial interface
• Global external awareness within the therapeutic area and global regulatory environment
• Ability to travel nationally and internationally

At AstraZeneca, we trust in the science. Driven by it and united by it, this is the place where great science comes alive. It’s our smart thinking and patience that helps us to push the boundaries of science to deliver life-changing medicines. If you have a true love of science and believe in its potential to redefine the possible, then this is the place for you.