Global Development Medical Director

AstraZeneca•Gaithersburg, MD
•$241,613 - $362,420•Hybrid

About The Position

The Global Development Medical Director in Late Phase Cardiovascular, Renal, and Metabolic (CVRM) development provides medical leadership for clinical trials, with a focus on cardiovascular/renal or metabolic dysfunction, including diabetes, obesity, and NASH/MASH. The role is responsible for trial design, conduct, monitoring, data interpretation, and reporting to ensure the collected clinical data can establish the compound’s benefits and risks and support the intended label indication and global pricing. The role operates in accordance with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements. The Medical Director provides strategic medical and scientific expertise throughout the clinical study lifecycle and responds to medical information requests from regulators, ethics committees, marketing companies, investigators, and sites. The role is accountable to the Global Clinical Head for study medical aspects and design, works with the Study Team to make decisions and resolve medical issues, and oversees study medical and ethical components, including patient safety. Responsibilities include delivering study documents, conducting study-level safety surveillance, supporting investigator meetings and national activities, and approving Clinical Study Reports with the Global Clinical Head. The role also maintains awareness of emerging medical developments, engages strategically with external stakeholders, and guides investigator-initiated trials with regional marketing companies. The position offers an annual base pay range of $241,613–$362,420 USD, a short-term incentive bonus opportunity, and eligibility for an equity-based long-term incentive program. Benefits include a qualified retirement program (401(k)), paid vacation and holidays, paid leaves, and health benefits including medical, prescription drug, dental, and vision coverage. The company expects employees to work from the office an average of at least three days per week, while allowing individual flexibility.

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 implementing clinical trials, and 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 clinical studies.
  • Provide 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 Study Team remits with other Study Team members and help resolve medical issues.
  • Oversee medical and ethical components of studies, including patient safety and 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 the Clinical Study Report with the Global Clinical Head, including preparation and production of the introduction, results, and 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 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.
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