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AstraZeneca

Global pharmaceutical company developing prescription medicines

Global Clinical Program Lead - Late Respiratory and Immunology Clinical Development

Clinical Research OperationsUpdated on Nov 9
Full-timeCambridge, MA, USA

About the Job

Requirements

  • An M.D., Ph.D., or equivalent medical or scientific qualification is required.
  • At least 5–8 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.
  • Excellent written and verbal English communication skills are required.
  • Ability to work effectively across global teams and travel as required is required.

Responsibilities

  • Be accountable to the Global Clinical Head for a significant proportion of the clinical program, usually an indication-aligned cluster of clinical studies.
  • Supervise a team of Global Development Medical Directors and/or Global Development Scientist Directors, and work cross-functionally to support the design, conduct, monitoring, and data interpretation of multiple studies.
  • Ensure clinical data collected within studies can determine compound benefits and risks and meet the needs of the intended label indication and price in global markets.
  • Set the vision and goals against 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 program-aligned publications; and seek and share findings across the portfolio of studies.
  • Operate according to ethical standards and comply with internal standard operating procedures, local regulations, laws, Good Clinical Practice, and regulatory requirements.
  • 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 materials, 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 play a key role in preparing and producing relevant sections, including the introduction, results, and discussion.
  • Induct and educate new Global Study Team members.
  • Contribute, as applicable, to clinical trial improvement workstreams on behalf of the Clinical function.
  • Identify risks and propose mitigation strategies to deliver successful phase IIb, III, IV, or life-cycle-management studies, reporting 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/sites; provide clarifications and resolve clinical, scientific, and medical issues in the Global Study Team.
  • Serve as the clinical representative for the indication on Global and Clinical Product Teams and/or sub-teams.
  • Co-lead study and program publication strategy and publication approval with the Global Clinical Head.
  • Line-manage project study physicians and scientists.

Desired Qualifications

  • Strong analytical, problem-solving, teamwork, and influencing skills.
  • Strong presentation and stakeholder engagement capabilities.

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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