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AstraZeneca

Global pharmaceutical company developing prescription medicines

Global Development Medical Director

Biology & BiotechConfirmed live in the last 24 hours
Full-timeGaithersburg, MD, USA

About the Job

Requirements

  • Graduate of a recognized school of medicine with an M.B.B.S. or M.D. degree, with specialty or experience in the Cardiovascular, Renal, or Metabolism therapeutic areas, including obesity, diabetes, and 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 leading and communicating clearly across countries and cultures.
  • Fluency in oral and written English, with good presentation skills and effective communication.

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 Study Team remits with other members and resolve medical issues with the study team.
  • Oversee the medical and ethical components of studies, including patient safety and compliance with Good Clinical Practice.
  • Deliver 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, 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 preparing and producing its introduction, results, and discussion.
  • Maintain 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 company products.
  • Provide guidance for investigator-initiated trials in collaboration with regional marketing companies.

Desired Qualifications

  • Clinical research expertise in the relevant therapeutic area, including study design, protocol development, monitoring and implementation of clinical trials, and interpreting and reporting trial results.
  • Credibility in scientific and commercial environments.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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