Global Clinical Head- Executive Director

AstraZeneca•Gaithersburg, MD
•$331,874 - $497,810•Hybrid

About The Position

The Global Clinical Head (GCH) provides overall clinical leadership for one or more global products in the Infectious Disease pipeline. The role develops medical and scientific strategies for the clinical components of the Target Product Profile (TPP), Clinical Development Plan (CDP), and regulatory documents, including briefing documents, CTD/BLA submissions, and core labelling texts. As part of the Clinical Project Team, the GCH is accountable for the clinical, scientific, and value content and timely, high-quality delivery of the program’s medical components. The GCH represents the team on the Global Project Team, which oversees the overall strategy for Infection products. The position is based at AstraZeneca’s Gaithersburg site and requires working from the office at least three days per week. The company describes its working approach as balancing in-office expectations with individual flexibility.

Requirements

  • MD degree or equivalent from a recognized school of medicine.
  • 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 program strategy and be accountable for project plans, timelines, progress, and outcomes.
  • Experience with global regulatory submissions, interactions with major Health Authorities, regulatory document writing and filings (such as 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, 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 excellent cross-functional collaborations.
  • Excellent verbal and written communication skills in English, including the ability to communicate at multiple organizational levels and give presentations.
  • High integrity.
  • Demonstrated AI/digital mindset and experience applying AI-enabled and generative AI tools to clinical development activities.

Nice To Haves

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

Responsibilities

  • Provide overall clinical leadership for one or more global products in the Infectious Disease pipeline.
  • Develop medical and scientific strategies for clinical components of the Target Product Profile, Clinical Development Plan, and regulatory documents.
  • Be accountable for the clinical, scientific, and value content and the timely, high-quality delivery of the program’s medical components.
  • Represent the team on the Global Project Team overseeing the overall strategy of Infection products.
  • Lead program strategy and be accountable for project plans, timelines, progress, and outcomes.
  • Lead, motivate, coach, and mentor physicians and clinical scientists in a matrix environment.
  • Interact with major Health Authorities and contribute to global regulatory submissions, regulatory writing, and filings.
  • Organize and deliver Advisory Boards with international Key External Experts.
  • Apply AI-enabled and generative AI tools to support clinical development activities, such as data analysis, medical writing, and clinical trial operational efficiency.
  • Work from the Gaithersburg AstraZeneca office at least three days per week.

Benefits

  • Short-term incentive bonus opportunity.
  • Eligibility to participate in the equity-based long-term incentive program for salaried roles.
  • Qualified retirement program (401(k) plan).
  • Paid vacation and holidays.
  • Paid leaves.
  • Medical, prescription drug, dental, and vision coverage.

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What This Job Offers

Job Type

Full-time

Career Level

Executive

Education Level

Ph.D. or professional degree

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