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AstraZeneca

Global pharmaceutical company developing prescription medicines

Senior Global Development Medical Director

Biology & BiotechConfirmed live in the last 24 hours
Full-timeGaithersburg, MD, USA

About the Job

Requirements

  • Hold an M.B.B.S., M.D., Ph.D., or equivalent medical or scientific qualification.
  • Have at least 5–8 years of relevant clinical development experience, including study design, protocol development, trial implementation, monitoring, data interpretation, and reporting.
  • Have experience in clinical development and working within cross-functional teams.
  • Have knowledge of biostatistics, global regulatory requirements, pharmacovigilance, Good Clinical Practice, and clinical trial safety.
  • Have strong analytical, problem-solving, teamwork, and influencing skills.
  • Have excellent written and verbal English communication skills.
  • Have strong presentation and stakeholder engagement capabilities.
  • Be able to work effectively across global teams and travel as required.

Responsibilities

  • Provide strategic medical and scientific expertise throughout the design, initiation, execution, completion, and interpretation of clinical studies.
  • Lead study design concepts and establish clear objectives for clinical programs and individual studies.
  • Provide medical expertise with Product Teams and support interpretation of clinical and safety data.
  • Deliver medical information and responses to regulatory authorities, ethics committees, investigators, study sites, and Marketing Companies.
  • Maintain current knowledge of relevant literature, treatment guidelines, and emerging medical developments.
  • Provide medical accountability to the Global Clinical Head for assigned studies.
  • Drive medical decisions within the Study Team and resolve clinical issues.
  • Ensure studies meet ethical, safety, Good Clinical Practice, regulatory, and company standards.
  • Provide medical input into protocols, statistical analysis plans, amendments, informed consent forms, case report forms, safety plans, and risk-based monitoring plans.
  • Oversee study-level safety surveillance, including adverse events and serious adverse event reporting, data queries, blinded safety review, and escalation of emerging concerns.
  • Support international investigator meetings and national activities.
  • Prepare and approve Clinical Study Reports with the Global Clinical Head, including the Introduction, Results, and Discussion sections.
  • Identify study risks and propose mitigation strategies for Phase IIb, Phase III, Phase IV, and life-cycle management studies.
  • Contribute to publications and congress presentations.
  • Provide medical input into core labelling texts, support commercial activities, and contribute scientific expertise to pricing and value strategies.

Desired Qualifications

  • Have expertise in CVRM nephrology, cardiology, cardiovascular disease, chronic kidney disease, diabetes, obesity, metabolic disease, NASH, or MASH.
  • Have experience with Phase IIb, Phase III, Phase IV, outcomes, or life-cycle management studies.
  • Understand pharmaceutical R&D milestones and the interaction between clinical, commercial, regulatory, safety, market access, pricing, and value objectives.
  • Have experience with regulatory submissions, publications, congress presentations, investigator-initiated studies, or external alliance partnerships.
  • Have experience contributing to labelling, payer evidence, or commercial medical strategies.

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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