Senior Global Development Medical Director

AstraZeneca•Gaithersburg, MD

5d•$288,059 - $432,088•Hybrid

About The Position

AstraZeneca is seeking a Senior Global Development Medical Director to provide clinical and scientific leadership across global development programs in Cardiovascular, Renal and Metabolic Diseases (CVRM). As a Research Physician or Scientist, you will work within cross-functional global teams to design, conduct, interpret, and report clinical studies. You will collaborate with the Global Clinical Head, regulatory agencies, external medical experts, alliance partners, investigators, and internal stakeholders to advance medicines through development and toward patients. The role also includes contributing to publications and congress presentations, providing medical input into core labelling texts, supporting commercial activities, and contributing scientific expertise to pricing and value strategies.

Requirements

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.
Experience in clinical development and working within cross-functional teams.
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.
Ability to work effectively across global teams and travel as required.

Nice To Haves

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

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 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.