Global Clinical Program Architect

CSL; King of Prussia (PA); On-site; USD 180,000 - 260,000; Full time

Job summary

CSL Behring is seeking a Global Clinical Program Leader to design and execute the clinical strategy for a medicine, aligned with the PSD and TPP. You will lead the Clinical Development Team in a matrix environment and ensure compliance with GCP and ICH.

The role covers clinical and scientific oversight, medical monitoring, and authoring key study documents for regulatory submissions, with collaboration on cross-functional teams such as PST, SET, SMT, BRAT, BET and EAST.

Qualifications

• 3–5 years of relevant clinical development experience
• Extensive clinical development industry experience with regulatory processes
• Proven leadership in a matrix environment and cross-functional collaboration

Responsibilities

• Provide leadership to the Clinical Development Team (CDT) and ensure timely development of the CDP
• Oversee clinical and scientific oversight across assigned programs and ensure high quality standards
• Lead authorship of key study documents and support regulatory packages (INDs/NDAs/BLAs) and publication efforts

Skills

Program leadership

Stakeholder management

Project management

Clinical development

Medical writing

Risk mitigation

Analytical thinking

Education

MD/PhD/PharmD

MD Board Certified or international equivalent

Job description

CSL Behring is seeking a Global Clinical Program Leader to design and execute the clinical strategy for a medicine, aligned with the PSD and TPP. You will lead the Clinical Development Team in a matrix environment and ensure compliance with GCP and ICH.

The role covers clinical and scientific oversight, medical monitoring, and authoring key study documents for regulatory submissions, with collaboration on cross-functional teams such as PST, SET, SMT, BRAT, BET and EAST.