Global Clinical Program Lead – Immunology Cell Therapy

Global Clinical Program Lead – Immunology Cell Therapy

Requirements

• 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 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.

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 partnerships 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.

Preferred Qualifications

• 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.