Global Clinical Program Lead, Immunology Cell Therapy

Clinical Program Lead (GCPL), 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, substantial clinical development experience in Immunology and CAR-T cell therapies, deep know-how of standing up these studies in immune mediated diseases? 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 (GCPL) 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, 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 are responsible for spearheading site engagement and activating our key trials across our cell therapy portfolio for 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.

Responsibilities:

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

• 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

• Collaborated with internal and external partners at a local and global level to establish clinical site networks, relationships and strategic partners ship to enable clinical development and commercialization.

• Accountable for clinical scientific aspects of the cell therapies in immune mediated diseases, including the benefit/risk of a product and/or asset as well as Clinical components of regulatory documents, medical monitoring and ensuring timely delivery of studies and site activations.

• Provide impactful medical strategy and cell therapy expertise to Discover, Translational Medicine and Commercial Partners, including in the development of therapeutic area strategy

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 5 or more of expertise & experience in both the clinical setting and the drug development process, specifically in designing development strategies and delivering Phase 1-3 programs coupled with the appropriate regulatory and commercial insights required to achieve a successful product approval and launch.

• Extensive experience as clinical trialist in the immunology therapeutic area 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.

• Experience in both academic and industry for clinical development.

• Global external awareness within the therapeutic area and global regulatory environment

• Detailed understanding of clinical research methodology and biostatistics principles.

• Thorough command of FDA, EMA, MHRA and ICH GCP guidelines.

• 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

• Track record of contributing and leading successful high performing global cross-functional team as well as line management experience.

• Strong leader and contributor seen as credible with Key Opinion Leaders, Payers and Scientific communities.

• Strong vision and excellent problem-solving skills, passionate, and have the drive to succeed.

• Entrepreneurial in the style of working and have the energy level to create a group of motivated individuals

• Ability to communicate and influence at high levels with both internal and external stakeholders.

• Proven ability to learn new information rapidly and effectively

Desirable Skills/Experience:

• Immunology, Rheumatology, Transplant, Neurology, Endocrinology, Gastroenterology or other internal medicine specialty Physician board certified or board eligible

• 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.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.