Senior Director Global Clinical Program Lead Cardiovascular & Renal
CSL Behring
Not specified
Clinical development plan execution
Gcp and ich regulation compliance
Medical monitor responsibilities
CSL Behring is seeking a Senior Director Global Clinical Program Lead for Cardiovascular & Renal to oversee the clinical strategy and execution of clinical development plans. The ideal candidate should possess significant clinical development experience and hold an MD, preferably with board certification in a relevant field
Job Summary
The role is accountable for the design and execution of clinical strategy to support the development of a medicine aligned with the Project Strategy Document.
This position serves as a Lead Author or Contributing Author for key study documents including Clinical Study Protocols, Investigator Brochures, and Regulatory packages.
CSL Behring operates one of the world's largest plasma collection networks and delivers lifesaving therapies to people in more than 100 countries.
Matching Summary
Match Score: 85
CSL Behring is seeking a Senior Director Global Clinical Program Lead for Cardiovascular & Renal to oversee the clinical strategy and execution of clinical development plans. The ideal candidate should possess significant clinical development experience and hold an MD, preferably with board certification in a relevant field.
Skills & Requirements
Must-have
Clinical Development Plan execution
GCP and ICH regulation compliance
Medical monitor responsibilities
Regulatory package preparation
Cross-functional team leadership
Nice-to-have
Strategic decision making facilitation
Abstract and manuscript authorship
Safety Monitoring Committee presentation
Evidence and Access Strategy collaboration
Key Requirements
MD Board Certified in Cardiology or Internal Medicine
5+ years clinical development industry experience
Experience with IND, NDA, BLA regulatory processes