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AstraZeneca

Global pharmaceutical company developing prescription medicines

Global Clinical Program Lead

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeCambridge, UKNo salary listed

About the Job

Requirements

  • An M.D. with specialist training or significant experience in allergy, immunology, or autoimmune diseases is required.
  • At least 5 years of relevant clinical development experience, including study design, protocol development, trial implementation, monitoring, data interpretation, and reporting is required.
  • Experience in clinical development and working within cross-functional teams is required.
  • Knowledge of biostatistics, global regulatory requirements, pharmacovigilance, Good Clinical Practice, and clinical trial safety is required.
  • Strong analytical, problem-solving, teamwork, and influencing skills are required.
  • Excellent written and verbal English communication skills are required.
  • Strong presentation and stakeholder engagement capabilities are required.
  • Ability to work effectively across global teams and travel as required is necessary.

Responsibilities

  • Oversee clinical, scientific, and ethical components of studies, including patient safety at study and/or program level, in compliance with Good Clinical Practice.
  • Provide scientific medical input to relevant study documents, including protocols, statistical analysis plans, amendments, informed consent forms, case report forms, safety plans, and risk-based monitoring plans, ensuring consistency within the clinical program and alignment with 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 adverse event and serious adverse event reporting processes.
  • Review the Clinical Study Report with the Global Clinical Head and contribute to preparing and producing relevant sections, including the Introduction, Results, and Discussion.
  • Induct and educate new Global Study Team members.
  • Contribute to clinical trial improvement workstreams on behalf of the Clinical function, as needed.
  • Identify risks and propose mitigation strategies to deliver successful phase IIb, III, IV, or Life Cycle Management studies, remaining accountable to the Global Clinical Head and therapeutic area leadership.
  • Deliver clinical, scientific, and medical information and query responses to regulatory agencies, ethics committees, Marketing Companies, and investigators or sites; provide clarifications and resolve clinical, scientific, and medical issues in the Global Study Team.
  • Represent the clinical function for the indication on Global and Clinical Product Teams and/or sub-teams.
  • Co-lead study and program strategy for publication development and approval of publications with the Global Clinical Head.
  • Line manage project study physicians and scientists.
  • Set the vision and goals in line with therapeutic area leadership priorities and product strategy; ensure timely decision-making; balance cost, time, and quality against clinical development objectives; develop risk mitigation strategies; enable troubleshooting; represent the program in health authority interactions; review publications aligned to the program; and seek and share findings across the portfolio of studies.
  • Work cross-functionally to support the design, conduct, monitoring, and data interpretation of multiple studies.
  • Ensure clinical data collected in studies supports assessment of the compound’s benefits and risks and meets the needs of the intended label indication and price in global markets.
  • Operate in compliance with internal standard operating procedures, local regulations, laws, Good Clinical Practice, and regulatory requirements.

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

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