Global Development Medical Director

As aGlobal Development MedicalDirectorwith a focus onCardiovascular/RenalorMetabolic 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)isresponsible 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 individualoperatesaccording to the highest ethical standards to align with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements.

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.gProtocol, 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 StudyReport;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 strategicintent whenworking with Alliance partners, Regulatory Authorities, payers, opinion leaders,prescribersand consumers of AstraZeneca products

• Provide guidance forinvestigator-initiatedtrials in collaboration with regional marketing companies 

BasicQualifications:

• Graduate of a recognized school of medicine with an M.B.B.S. or M.D. degree, OR PhD OR PharmD

• Preferred specialty or experience in the Cardiovascular, Renal or Metabolism (including obesity, diabetes, MASH) therapeutic areas, 

• 3+ years of pharmaceutical industryexperience OR3+ 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 researchexpertisein relevant therapy area in study design, protocol development, monitoring and implementing clinical trials,interpretingand reporting trial results

• Credibility in scientific and commercial environments