Respiratory Clinical Development Director - Lead Trials

GSK

United States

Remote

USD 122,000 - 186,000

Full time

11 days ago

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Job summary

GSK seeks a Clinical Development Director to shape the future of its respiratory portfolio. You will lead the design and delivery of clinical studies across drug development stages and work with global teams to advance strategies that improve patient outcomes.

The role emphasizes collaboration, proactive problem‑solving, and clear communication. You will guide evidence generation, liaise with regulators, and drive leadership across matrix teams.

Qualifications

  • Bachelor’s degree in a science related field (required).
  • 3+ years of clinical training and/or clinical research experience; needs in planning and execution of trials.
  • Robust knowledge of ICH, GCP, FDA requirements and regulatory data needs.
  • Understanding of regulators, payers and prescribers in relevant markets.
  • Experience using digital tools to drive innovation in clinical research.
  • Solid understanding of clinical research methodology and biostatistics for trial design.
  • Ability to apply statistics and visualization to interpret complex data.

Responsibilities

  • Lead clinical development for respiratory programs with global teams.
  • Shape operational strategies to advance treatments for patients.
  • Support regulatory interactions including CTAs, CSPs, CSR and manuscripts.
  • Manage Integrated Evidence Plan (IEP) and Clinical Development Plan (CDP).
  • Ensure alignment with project plans, regulatory requirements and commercial goals.
  • Deliver clinical timelines and Go/No Go criteria for CDP.
  • Collaborate with Commercial, Regulatory, Clinical Operations and Statistics.
  • Act as clinical contact for senior management and external experts.
  • Influence external stakeholders to align with business strategy and patient needs.
  • Identify transformational opportunities to enhance patient impact.

Skills

Clinical research
Regulatory knowledge
Biostatistics
Leadership
Communication

Education

Bachelor's degree in science
PhD or PharmD valuable

Job description

GSK seeks a Clinical Development Director to shape the future of its respiratory portfolio. You will lead the design and delivery of clinical studies across drug development stages and work with global teams to advance strategies that improve patient outcomes.

The role emphasizes collaboration, proactive problem‑solving, and clear communication. You will guide evidence generation, liaise with regulators, and drive leadership across matrix teams.

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