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AstraZeneca

Global pharmaceutical company developing prescription medicines

Global Clinical Head Executive Director Infectious Disease

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 MD degree or equivalent.
  • Demonstrated clinical research expertise in infectious diseases and vaccines.
  • At least 10 years of pharmaceutical industry knowledge and experience.
  • Experience in early- and late-stage program development and trial conduct.
  • Demonstrated ability to lead the development of a program strategy and be accountable for project plans, timelines, progress, and outcomes.
  • Experience with global regulatory submissions, interacting with major health authorities, regulatory document writing and filings, including NDA/BLA submissions and benefit/risk assessment.
  • Demonstrated ability to lead and motivate teams in a matrix environment.
  • Demonstrated ability to lead, coach, and mentor physicians and clinical scientists.
  • Significant hands-on clinical drug development experience and scientific credibility.
  • Experience developing and delivering multiple complex and large studies in parallel, including multinational pivotal Phase 3 efficacy studies.
  • Clinical experience as a practicing physician in a hospital and/or clinic setting.
  • Demonstrated ability to cultivate cross-functional collaborations.
  • Ability to communicate effectively at multiple organizational levels, with verbal and written communication skills in English, including giving presentations.
  • High integrity.
  • Demonstrated AI/digital mindset and experience applying AI-enabled and generative AI tools to clinical development activities, such as data analysis, medical writing, and clinical trial operational efficiency.
  • Ability to be office-based at the Gaithersburg site at least three days a week.

Responsibilities

  • Provide overall clinical leadership for one or more global products in the infectious disease pipeline.
  • Develop medical/scientific strategies for the clinical components of the Target Product Profile, Clinical Development Plan, and regulatory documents, including briefing documents, CTD/BLA, and core labelling texts.
  • Within the Clinical Project Team, be accountable for the clinical, scientific, and value content and delivery of the program’s medical components to time and quality.
  • Represent the team and its voice on the Global Project Team overseeing the overall strategy of infection products.
  • Organize and deliver advisory boards with international key external experts.

Desired Qualifications

  • Named investigator on clinical trials.
  • Regulatory affairs expertise with a major health authority.
  • Experience progressing compounds into first-in-human Phase 1 studies and delivering Phase 2 proof-of-principle studies.
  • Significant and consistent peer-reviewed publication track record.

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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