Global Development Medical Director

AstraZeneca • Gaithersburg, MD

4d • Hybrid

About The Position

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.
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

Requirements

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

Nice To Haves

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

Responsibilities

• Provide strategic medical and scientific knowledge and support the design, initiation, execution, completion, and interpretation of a clinical study
• Deliver medical information, answers, and clarifications to Regulators, Ethics Committees, Marketing Companies, Investigators/Sites
• Accountable to the Global Clinical Head (GCH) for the medical aspects and design of studies
• 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)
• 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

Benefits

• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees