Senior Global Development Medical Director

Senior Global Development Medical Director

AstraZeneca is seeking aSenior Global Development Medical Directorto provide clinical and scientific leadership across global development programs inCardiovascular 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.

Key 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 least5-8 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.

Preferred experience

• Expertise inCVRM 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.

Key success factors

• Scientific credibility:Applies strong clinical expertise and sound judgment.
• Collaborative leadership:Builds trust and works effectively across functions cultures and geographies.
• Patient focus:Prioritizes patient safety ethical conduct and meaningful outcomes.
• Analytical rigor:Interprets data objectively and communicates clear balanced conclusions.
• Agility:Responds effectively to changing scientific operational and regulatory needs.
• External influence:Builds effective relationships with regulators investigators medical experts payers and partners.
• AstraZeneca values:Demonstrates integrity courage curiosity collaboration and accountability.

Compensation and working environment.

The annual base salary range is$288059 to $432088 annually USD depending on factors including location skills experience and qualifications. The role may also be eligible for a short-term incentive bonus and equity-based long-term incentive program subject to applicable terms.

AstraZenecas Gaithersburg site offers a collaborative and inclusive workplace with amenities including gym access networking events lunch-and-learn sessions and a sustainable office environment. Employees work from the office a minimum ofthree days per week subject to role requirements and applicable arrangements.

Why AstraZeneca

At AstraZeneca we follow science to develop life-changing medicines. We bring diverse teams together encourage bold thinking and create opportunities to make a meaningful difference for patients worldwide.

AstraZeneca is an equal opportunity employer committed to diversity inclusion and professional development.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.