Global Clinical Program Lead, Immunology

Global Clinical Product Leader, Immunology

Make a more meaningful contribution. Impact patients’ lives every day.

Contribute to our growing pipeline. Join a place with the commitment, knowledge and backing from the business to continue expanding our pipeline. With one of the broadest and deepest pipelines, we are determined to keep contributing and pushing forward. When we get it right there’s nothing more motivating.

AZ’s vision is to grow and expand the indications and assets in immunology to become a major player in the field. This Global Clinical Program Lead (GCPL) role in Late stage clinical development in Immunology is designed to help deliver on that ambition.

The role - Global Clinical Program Lead, Immunology

The individual is expected to work closely with the Business Development team and the Immunology teams to identify diseases where there remains an unmet medical need and assets to fill that need. In addition, the individual will be responsible for also considering how to develop and deliver clinical trials efficiently for immunological assets where the patient population may be small and care is centered in specialized tertiary centers. The GCPL will report into the VP of Late Stage Immunology Clinical Development.

What you’ll do:

• Responsible for liaising with Business Development team to identify new opportunities for investment in Immunology Assets
• Will be lead clinical reviewer for any Business Development Opportunities for Immunology
• Input into AZ’s strategy for Immunology as a member of the Immunology Disease Area Strategy Team representing Late Stage Immunology Clinical development in conjunction with VP of Immunology
• Input into AZ’s strategy for Immunology by serving as member of the Late Stage Clinical Development Team to identify where there are clinical and commercial opportunities in particular diseases to expand AZ’s footprint

• Leads development in conjunction with VP of Immunology, Patient Engagement Lead and Clinical Ops colleagues, of future clinical operation trial delivery and patient engagement strategy for potential immunologic indications
• Accountable for induction and education of new Global Study Team members. May also contribute to clinical trial improvement workstreams on behalf of the Clinical function.
• Delivery of clinical, scientific, and medical information/query responses to Regulatory Agencies, Ethic Committees, Marketing Companies (MCs), and investigators/sites, and provides clarifications as well as solves clinical, scientific, and medical issues in the Global Study Team
• Clinical representative on indication in Global and Clinical Product Teams and/or sub-teams
• Leads governance interactions in conjunction with or as delegated by the GCH such as DRACs, DRCs, PRCs
• Co-leads the study and program strategy for publication development and approval of publications with the GCH
• May have line management of project study physicians and scientists
• Maintains high degree of understanding and awareness on new and emerging medical development advances in the relevant therapeutic area globally.
• Builds trustworthy relationships with steering committees/executive committees, academic research organizations and clinical research organizations as applicable
• Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues
• Provides guidance for externally sponsored trials in cooperation with regional MCs
• Plays key role in development of the clinical sections of regulatory submission documents and is accountable to GCH for their content
• Provides a leadership role in writing responses to comments/questions of Regulatory Authorities for clinical modules
• Leads as delegated by GCH the strategy for the development of regulatory agency briefing documents (BD) and ensure BD completeness; defend BD positions during regulatory meetings as delegated by GCH

Basic Qualifications

• MD, MBBS, or other equivalent medical degree from an accredited university
• Minimum 5 years’ relevant experience within the immunology, rheumatology, allergy, or autoimmune space
• Knowledge of biostatistics, global regulatory environment, and pharmacovigilance relevant to the role
• Experience in leading or reviewing a clinical program to support an indication: design, clinical development plan and Target Product Profile.
• Good presentation skills and effective communication with internal and external collaborators
• Knowledge and experience to work across projects, with a fast-learning curve when moving into new disease areas