Global Development Medical Director

AstraZeneca • Gaithersburg, MD

3d • Hybrid

About The Position

The Global Development Medical Director in Late Phase Cardiovascular, Renal, and Metabolic diseases (CVRM) provides medical and scientific leadership for clinical trials, with a focus on cardiovascular/renal or metabolic dysfunction, including diabetes, obesity, and NASH/MASH. The role is responsible for the design, conduct, monitoring, data interpretation, and reporting of individual trials, ensuring that the study data can establish the compound’s benefits and risks and support the intended label indication and pricing in markets globally. The position operates in accordance with internal SOPs, local regulations and laws, Good Clinical Practice, and regulatory requirements.

The role provides medical and scientific input throughout the study lifecycle; delivers medical information and responses to regulators, ethics committees, marketing companies, investigators, and sites; and is accountable to the Global Clinical Head for study medical aspects and design. In collaboration with the study team, the director drives decisions, resolves medical issues, and oversees medical and ethical study components, including patient safety.

The director delivers key study documents, conducts study-level safety surveillance, supports investigator meetings and national activities, and works with the Global Clinical Head to approve Clinical Study Reports. The role also maintains awareness of emerging medical developments and applies strategic judgment in work with alliance partners, regulators, payers, opinion leaders, prescribers, consumers, and regional marketing companies.

Requirements

• Graduate of a recognized school of medicine with an M.B.B.S. or M.D. degree.
• Specialty or experience in cardiovascular, renal, or metabolism therapeutic areas, including obesity, diabetes, or MASH.
• At least 3 years of pharmaceutical industry experience or at least 3 years of clinical research experience in an academic or clinical practice setting.
• Demonstrated partnership and collaboration skills, including the ability to lead and communicate clearly across countries and cultures.
• Fluent oral and written English.
• Good presentation skills and effective communication.

Nice To Haves

• Clinical research expertise in a relevant therapeutic area, including study design, protocol development, monitoring and implementation of clinical trials, and interpretation and reporting of 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 clinical studies.
• Deliver medical information, answers, and clarifications to regulators, ethics committees, marketing companies, investigators, and sites.
• Be accountable to the Global Clinical Head for the medical aspects and design of studies.
• Drive decisions within the study team’s remit and resolve medical issues in collaboration with study team members.
• Oversee medical and ethical study components, including patient safety, in compliance with Good Clinical Practice.
• Deliver relevant study documents, including protocols, amendments, statistical analysis plans, informed consent forms, case report forms, and safety and risk-based monitoring plans.
• Conduct study-level safety surveillance, including adverse event and serious adverse event reporting processes, querying missing or unclear data, reviewing blinded safety data, and escalating issues to the Global Clinical Head or Global Safety Physician when needed.
• Be medically accountable for international investigator meetings and support marketing companies in national activities.
• Approve Clinical Study Reports with the Global Clinical Head, including preparation and production of the introduction, results, and discussion.
• Maintain awareness and understanding 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.
• Guide investigator-initiated trials in collaboration with regional marketing companies.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility to participate in an 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, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree