A

AstraZeneca

Global pharmaceutical company developing prescription medicines

Global Clinical Program Lead - Immunology

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeCambridge, MA, USA

About the Job

Requirements

  • A medical degree (MD or MD-PhD) is required, with specialist training or experience in gastroenterology/gastrointestinal diseases and/or clinical immunology.
  • A minimum of five years of pharmaceutical-industry experience is required, including experience leading clinical trials supporting approval in Phase 2–4.
  • Knowledge of biostatistics, the global regulatory environment, and pharmacovigilance relevant to the role is required.
  • Experience leading or reviewing a clinical program to support an indication, including design, clinical development plan, and Target Product Profile, is required.
  • Good presentation skills and effective communication with internal and external collaborators are required.
  • Ability to work across projects and learn quickly when moving into new disease areas is required.

Responsibilities

  • Provide medical and scientific input into clinical-stage small-molecule, biologic, or cell-therapy programs and provide program leadership in gastroenterology and clinical immunology.
  • Take responsibility for clinical development in cross-functional teams, supporting early- to late-phase clinical development activities, including overall clinical development plans, clinical study design, study concepts and protocols, key study and health-authority documentation, medical monitoring, and timely study delivery.
  • Deliver study design concepts.
  • Drive clinical and scientific decisions within Global Study Team remits with other team members.
  • Ensure clinical, scientific, and ethical components of studies, including patient safety at study and/or program level, comply with Good Clinical Practice.
  • Provide scientific medical input to relevant study documents, including protocols, statistical analysis plans, amendments, informed consent, case report forms, safety plans, and risk-based monitoring plans, ensuring consistency within the clinical program and alignment with its scientific rationale.
  • Provide scientific medical content at international investigator meetings and support local Marketing Companies with country-level activities.
  • Conduct safety surveillance at study and/or program level, including processes for Adverse Event and Serious Adverse Event reporting.
  • Review Clinical Study Reports with the Global Clinical Head and contribute to preparing and producing relevant sections, including Introduction, Results, and Discussion.
  • Induct and educate new Global Study Team members.
  • Work with the Global Clinical Head and Therapeutic Area leadership to identify risks and propose mitigation strategies for successful Phase IIb, III, IV, or Life Cycle Management studies.
  • Deliver clinical, scientific, and medical information and query responses to regulatory agencies, ethics committees, Marketing Companies, and investigators/sites; provide clarifications and resolve clinical, scientific, and medical issues within the Global Study Team.
  • Represent the indication clinically on Global and Clinical Product Teams and/or sub-teams.
  • Lead governance interactions, such as DRACs, DRCs, and PRCs, with or as delegated by the Global Clinical Head.
  • Co-lead study and program publication strategy and publication approval with the Global Clinical Head.
  • Line-manage project study physicians and scientists.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

Recently Posted Jobs

Explore more opportunities at AstraZeneca

See more jobs