Jobs · Maryland

Global Clinical Head- Executive Director

AstraZeneca · Gaithersburg, MD · 2 wk ago
Full-time

About the role

As Global Clinical Head, you will have overall clinical leadership of one or more global products in the Infectious Disease pipeline. You will be responsible for medical and scientific strategies for the clinical components of the Target Product Profile (TPP), Clinical Development Plan (CDP), and regulatory documents (e.g., briefing documents, CTD/BLA, core labelling texts). Within the Clinical Project Team, you will have accountability for the clinical, scientific, and value content and delivery of the medical components for the program to time and quality. You will serve as the team’s voice and representative on the Global Project Team that oversees the overall strategy of Infection products.

Responsibilities

  • Provide clinical leadership for global Infectious Disease products in the pipeline.
  • Develop and execute medical and scientific strategies for clinical components of the Target Product Profile (TPP) and Clinical Development Plan (CDP).
  • Lead the preparation of regulatory documents, including briefing documents, CTD/BLA, and core labelling texts.
  • Oversee clinical, scientific, and value content delivery within the Clinical Project Team to ensure timelines and quality standards are met.
  • Represent the clinical team on the Global Project Team, contributing to the overall strategy of Infection products.
  • Lead and motivate cross-functional teams in a matrix environment, including physicians and clinical scientists.
  • Organize and deliver Advisory Boards with international Key External Experts.
  • Apply AI/digital tools to support clinical development activities, such as data analysis, medical writing, and clinical trial operational efficiency.

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 experience.
  • Experience in early and late-stage program development and trial conduct.
  • Proven ability to lead program strategy development, project plans, timelines, progress, and outcomes.
  • Experience with global regulatory submissions, interactions with major Health Authorities, and regulatory document writing and filings (e.g., NDA/BLA submissions, benefit/risk assessment).
  • Significant hands-on clinical drug development experience and scientific credibility.
  • Experience developing and delivering complex, large-scale studies (e.g., multinational, pivotal Phase 3 efficacy studies).
  • Clinical experience as a practicing physician in hospital and/or clinic settings.
  • Ability to cultivate excellent cross-functional collaborations.
  • Strong verbal and written communication skills in English, including delivering presentations.
  • High integrity and ethical standards.
  • Office-based at the Gaithersburg AstraZeneca site at least 3 days a week.

Desired Qualifications

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

Benefits

  • Qualified retirement program (401(k) plan).
  • Paid vacation and holidays.
  • Paid leaves.
  • Health benefits, including medical, prescription drug, dental, and vision coverage.
  • Short-term incentive bonus opportunity.
  • Eligibility to participate in an equity-based long-term incentive program (for salaried roles) or retirement contribution (for hourly roles).

Pay

The annual base salary for this position ranges from USD 331,873.60 to 497,810.40, with variations based on market location, job-related knowledge, skills, and experience. Additional compensation may include a short-term incentive bonus and participation in an equity-based long-term incentive program.

Schedule

This role requires in-office presence at the Gaithersburg AstraZeneca site at least 3 days a week, with flexibility for individual work arrangements.

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