Jobs · Maryland

Global Development Medical Director, Late Respiratory and Immunology Clinical Development

AstraZeneca · Gaithersburg, MD · 5 days ago
$242k–$362k/yrFull-time

About the role

You will support the clinical project team and assist the Global Clinical Project Leader and Global Clinical Head with the design & interpretation process, establishing clear design objectives for clinical programs and studies. You will provide medical input into the content of core labelling texts and medical support for commercial activities, support for medical monitoring of clinical studies. And, you will also provide medical and scientific expertise as well as tactical and strategic medical input to the development of AstraZeneca’s compounds; primarily from Phase IIb to Phase IV.

This includes the design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of Respiratory and Immunology products in late-stage development.

Responsibilities

  • Provide medical and scientific leadership in the global development of new medicines targeted at indications in the field of respiratory diseases and wider range of immunological disorders
  • Have an important role providing medical and scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs
  • Build strong relationships with a network of external scientific experts
  • Work closely with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations
  • Be involved primarily in late stage (Ph2b and later) clinical programs while also collaborating with clinical colleagues supporting Early (R&I) stage programs and medical affairs
  • Lead and contribute to medical monitoring of trials
  • Provide expert medical input into the preparation of regulatory documents and interactions with regulatory authorities
  • Provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature
  • Develop and review protocols, informed consent, investigator’s brochure and other clinical development documents
  • Participate in the preparation of scientific publications and presentations at scientific meetings and congresses

Requirements

MD or MD/PhD
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

Qualifications

  • Pulmonary medicine, Immunology, Rheumatology, Allergy, or Dermatology background is desirable

Skills

Basic Qualifications
MD or MD/PhD
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

Benefits

  • Annual base pay range: $241,613 – $362,420 USD
  • Short-term incentive bonus opportunity
  • Equity-based long-term incentive program
  • Benefits include:
  • A 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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