Senior Global Development Medical Director

About the Company

About the Role

Responsibilities

• ● Medical and scientific leadership
• ● 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. Clinical trial delivery and safety
• ● 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 the highest ethical, safety, GCP, regulatory, and AstraZeneca 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. Essential qualifications
• ● M.B.B.S., M.D., Ph.D., or equivalent medical or scientific qualification.
• ● At least 5-8 years of relevant clinical development experience , including study design, protocol development, trial implementation, monitoring, data interpretation, and reporting.
• ● Knowledge of biostatistics, global regulatory requirements, pharmacovigilance, GCP, and clinical trial safety.
• ● Strong analytical, problem-solving, teamwork, and influencing skills.
• ● Excellent written and verbal English communication skills.
• ● Strong presentation and stakeholder engagement capabilities.