Global Clinical Program Lead, Immunology

AstraZeneca•Gaithersburg, MD

About The Position

The Global Clinical Program Lead (GCPL) in Immunology provides medical and scientific input and program leadership for clinical-stage cell therapy assets, with a focus on rheumatology and clinical immunology. The role is responsible for clinical development within cross-functional teams, supporting early- through late-phase activities, including development plans, study design, study concepts and protocols, key study and health authority documentation, medical monitoring, and timely study delivery. The GCPL is accountable for the clinical, scientific, and ethical aspects of studies, including patient safety and Good Clinical Practice compliance. The role contributes medical and scientific input to study documents, safety surveillance, investigator meetings, study reporting, and communications with regulatory agencies, ethics committees, marketing companies, investigators, and study sites. The GCPL also supports study and program strategy, governance interactions, publication development, risk mitigation, and onboarding and education of Global Study Team members.

Requirements

Medical degree (MD or MD-PhD).
Specialist training or experience in rheumatology and/or clinical immunology.
At least 5 years of experience in the pharmaceutical industry, including experience leading clinical trials to support approval in Phases 2–4.
Knowledge of biostatistics, the global regulatory environment, and pharmacovigilance relevant to the role.
Experience leading or reviewing a clinical program to support an indication, including study design, clinical development plans, and Target Product Profiles.
Good presentation skills and effective communication with internal and external collaborators.
Knowledge and experience working across projects, with the ability to learn quickly when moving into new disease areas.

Nice To Haves

Experience in CAR-T or other engineered cell therapies and/or T-cell engagers in autoimmune or inflammatory indications.
Familiarity with cell-therapy operational constraints, including chain-of-identity/control and vein-to-vein logistics, and with CMC-clinical interfaces.
Experience in Sjogren’s Disease or myositis.
Experience working effectively with cross-functional partners across clinical development and commercial organizations.
Awareness of the evolving external landscape in rheumatology, including scientific, clinical, competitive, and regulatory developments.
Ability to travel nationally and internationally.

Responsibilities

Deliver study design concepts.
Drive clinical and scientific decisions within Global Study Team remits in collaboration with other team members.
Oversee clinical, scientific, and ethical components of studies, including patient safety at study and/or program level and compliance with Good Clinical Practice.
Provide medical and scientific input to study documents, including protocols, statistical analysis plans, amendments, informed consent forms, case report forms, safety plans, and risk-based monitoring plans, ensuring consistency across the clinical program and alignment with scientific rationale.
Provide scientific and medical content for international investigator meetings and support country-level activities with local Marketing Companies.
Oversee study- and/or program-level safety surveillance, including Adverse Event and Serious Adverse Event reporting processes.
Review Clinical Study Reports with the GCH and contribute to relevant sections, including Introduction, Results, and Discussion.
Induct and educate new Global Study Team members.
Work with the GCH and therapeutic area leadership to identify risks and propose mitigation strategies for Phase IIb, III, IV, or Life Cycle Management studies.
Provide clinical, scientific, and medical information and query responses to regulatory agencies, ethics committees, Marketing Companies, investigators, and sites; clarify and resolve related issues within the Global Study Team.
Represent the clinical function for the indication in Global and Clinical Product Teams and/or sub-teams.
Lead governance interactions, in conjunction with or as delegated by the GCH, including DRACs, DRCs, and PRCs.
Co-lead study and program publication strategy and publication approvals with the GCH.