Global Clinical Program Lead — Strategic Medical Development

CSL

Waltham, King of Prussia (MA, PA)

On-site

USD 170,000 - 250,000

Full time

5 days ago
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Job summary

CSL Behring seeks a Global Clinical Program Lead responsible for designing and executing clinical strategies for its medicine development programs. You will lead the Clinical Development Team, ensure study quality, and maintain alignment with GCP/ICH standards.

The role requires an advanced life sciences degree and substantial clinical development experience, with strong leadership, writing and regulatory submission capabilities across cross-functional teams.

Qualifications

  • Advanced degree required (MD/PhD/PharmD) in life sciences or healthcare.
  • Extensive clinical development knowledge and regulatory understanding are essential.
  • 3–5+ years of relevant clinical development experience in pharma/biotech.

Responsibilities

  • Provide clinical and scientific leadership for CSL Behring clinical programs.
  • Develop and execute the Clinical Development Plan (CDP) aligned with PSD and TPP.
  • Oversee cross-functional teams and ensure GCP/ICH compliance across studies.
  • Act as medical monitor or provide oversight to medical monitors on trials.
  • Lead authorship of key study documents (CDP, PSD, IB, CSP, CSR) and regulatory submissions.

Skills

Program leadership
Stakeholder management
Project management
Clinical writing
Clinical data analysis
Analytical thinking
Communication skills

Education

Advanced degree in life science/healthcare

Job description

CSL Behring seeks a Global Clinical Program Lead responsible for designing and executing clinical strategies for its medicine development programs. You will lead the Clinical Development Team, ensure study quality, and maintain alignment with GCP/ICH standards.

The role requires an advanced life sciences degree and substantial clinical development experience, with strong leadership, writing and regulatory submission capabilities across cross-functional teams.

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