Global Development Medical Director
AstraZeneca
Summary
As a Global Development Medical Director with a focus on Cardiovascular/Renal or Metabolic dysfunction (including Diabetes, Obesity and NASH/MASH), you play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. The Global Development Medical Director in Late Phase CVRM (Cardiovascular, Renal, and Metabolic diseases) is responsible for the design, conduct, monitoring, data interpretation and reporting of individual clinical trials ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound, as well as allow for the intended label indication and price in markets globally. The individual operates according to the highest ethical standards to align with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements.
Job description
Medical expert accountabilities
- Provide strategic medical and scientific knowledge and support the design, initiation, execution, completion, and interpretation of a clinical study
- Accountable to deliver medical information, answers, and clarifications to Regulators, Ethics Committees, Marketing Companies, Investigators/Sites
Trial conduct and hands-on delivery accountabilities
- Accountable to the Global Clinical Head (GCH) for the medical aspects and design of studies. Also responsible for driving decisions within Study Team (ST) remits together with other ST members and for solving medical issues with the study team
- Oversight of medical and ethical components of studies including patient safety in compliance with GCP
- Deliver all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans)
- Conduct safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting, the querying of missing/unclear data, the review of blinded safety data, and escalation to the GCH/Global Safety Physician when needed
- Medically accountable for international investigator meetings, and support Marketing Companies in national activities
- Approve, with the GCH, the Clinical Study Report; including preparation and production (Introduction, Results, Discussion)
Messaging and external impact accountabilities
- Maintain a high degree of understanding and awareness of new and emerging medical developments, globally
- Apply strategic intent when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products
- Provide guidance for investigator-initiated trials in collaboration with regional marketing companies
Basic Qualifications
- Graduate of a recognized school of medicine with an M.B.B.S. or M.D. degree with specialty or experience in the Cardiovascular, Renal or Metabolism (including obesity, diabetes, MASH) therapeutic areas
- 3+ years of pharmaceutical industry experience OR 3+ years of clinical research experience in the academic or clinical practice setting
- Demonstrated partnership and collaboration skills, including acting as the leader and clearly communicating across countries and cultures
- Fluent in oral and written English, with good presentation skills and effective communication
Desired Qualifications
- Clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
- Credibility in scientific and commercial environments
Requirements
- M.B.B.S. or M.D. degree from a recognized school of medicine
- Specialty or experience in Cardiovascular, Renal or Metabolism (including obesity, diabetes, MASH) therapeutic areas
- 3+ years of pharmaceutical industry experience OR 3+ years of clinical research experience in academic or clinical practice setting
- Demonstrated partnership and collaboration skills, including acting as the leader and clearly communicating across countries and cultures
- Fluent in oral and written English, with good presentation skills and effective communication
- Clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
- Credibility in scientific and commercial environments
Benefits
- 401(k) Matching
- Paid Vacation
- Paid Holidays
- Paid Leaves
- Medical, Dental & Vision
- Prescription Drug Coverage
- Short-term Incentive Bonus
- Equity-based Long-term Incentive
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.