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Director IVD Strategy - Operations
A company is looking for a Director IVD Strategy & Operations in the Precision Medicine Unit. Key Responsibilities: Develop cross-functional RACI on strategy and implementation of IVD results and lead cross-functional forum to drive consensus and decisions across the enterprise Conduct frequent gap assessments to ongoing and new CDx studies and ensure coordinated cross-functional implementation of new IVD regulations Establish and lead a cross-functional IVD committee to develop the company's position and strategy to align with global IVD regulations Required Qualifications: Doctorate degree and 4 years of directly related industry experience, or Master's degree and 7 years, or Bachelor's degree and 9 years of directly related industry experience Advanced degree in life sciences, regulatory affairs, or a related field is preferred 10+ years of experience in biopharma, focusing on clinical operations, development, or regulatory affairs Deep understanding of IVDR, LDT regulations, FDA policies, and global CDx regulatory frameworks Proven leadership experience in building and managing cross-functional teams
A company is looking for a Director IVD Strategy & Operations in the Precision Medicine Unit.
Key Responsibilities:
Develop cross-functional RACI on strategy and implementation of IVD results and lead cross-functional forum to drive consensus and decisions across the enterprise
Conduct frequent gap assessments to ongoing and new CDx studies and ensure coordinated cross-functional implementation of new IVD regulations
Establish and lead a cross-functional IVD committee to develop the company's position and strategy to align with global IVD regulations
Required Qualifications:
Doctorate degree and 4 years of directly related industry experience, or Master's degree and 7 years, or Bachelor's degree and 9 years of directly related industry experience
Advanced degree in life sciences, regulatory affairs, or a related field is preferred
10+ years of experience in biopharma, focusing on clinical operations, development, or regulatory affairs
Deep understanding of IVDR, LDT regulations, FDA policies, and global CDx regulatory frameworks
Proven leadership experience in building and managing cross-functional teams