Global Development Medical Director

As a Global Development Medical Director, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The successful Study Clinical Lead in Late Phase CVRM (Cardiovascular, Renal, and Metabolic diseases) will be 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 will allow for the intended label indication and price in markets globally. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements. 

Responsibilities

• Provides strategic medical and scientific knowledge (Cardiovascular, Renal, Metabolic, and/or Hepatic Diseases) and supports the design, initiation, execution, completion, and interpretation of a clinical study 

• Is accountable for study designs  

• Is accountable to deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites 

Trial conduct and hands-on delivery accountabilities 

• Is accountable to the Global Clinical Head (GCH) or delegate for the medical aspects and designs of studies 

• Is responsible for driving decisions within Study Team (ST) remits together with other ST members and for solving medical issues in the study team 

• Is accountable for the medical and ethical components of studies including patient safety on a study level in compliance with GCP 

• Is accountable for delivery of the clinical components of all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans) 

• Is accountable for ensuring that 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 the escalation to the GCH/Global Safety Physician when needed. 

• Is medically accountable for international investigator meetings, and supports Marketing Companies (MC) in national activities 

• Approves (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion). 

• Is accountable for ST induction and education of new members in the study team, as well as others involved in the study 

• Collaborates seamlessly and efficiently with global colleagues at other R&D sites 

• May be accountable to GCH (or delegate) and leadership for identifying risks and proposing mitigation strategies to deliver successful Phase II, III, IV or Life Cycle Management studies 

Scientific medical analytical accountabilities 

• Stays updated on relevant scientific literature 

• Delivers analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation 

• Serves as a source of medical expertise for the Product Team, in analyses and interpretation of medical data 

Messaging and external impact accountabilities 

• Maintains a high degree of understanding and awareness on new and emerging medical development, globally. 

• Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues 

• Applies strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products 

• Able to provide guidance for investigator-initiated trials in cooperation with regional marketing companies  

Minimum Requirements  

• Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree or equivalent, and/or a graduate of a scientific doctorate (e.g. PhD or PharmD) or equivalent in a scientific discipline or Pharmaceutical Medicine