Director, Precision Medicine & IVD Strategy

Lever, Inc.; Cambridge (MA); On-site; USD 200,000 - 250,000; Full time

Job summary

Precede Biosciences is seeking an experienced Director, Precision Medicine and IVD Development to define IVD product strategy, drive the precision medicine roadmap, and lead cross-functional teams spanning translational science, clinical, regulatory, computational biology, and R&D.

The role requires diagnostic industry expertise and a successful track record launching molecular diagnostics in pharma partnerships and direct-to-clinic models, with global experience across US and international

Qualifications

• 10+ years in developing NGS-based IVDs or molecular diagnostics.
• Experience launching diagnostics through LDT and CDx pathways.
• Collaboration with biopharma and academic partners.

Responsibilities

• Develop and own IVD product strategy across companion diagnostics and LDT products.
• Define clinical reporting strategy for novel biomarkers and validation evidence.
• Lead maturation of the IVD product development function with processes and best practices.
• Partner with R&D, Translational Science and Biopharma to translate needs into specifications.
• Collaborate with regulatory to define strategy (LDT vs FDA submission) for each product.

Skills

Strategic thinking

Cross-functional leadership

Communication

Data-driven decisions

Entrepreneurial mindset

Education

PhD or MD in life sciences

Job description

Precede Biosciences is seeking an experienced Director, Precision Medicine and IVD Development to define IVD product strategy, drive the precision medicine roadmap, and lead cross-functional teams spanning translational science, clinical, regulatory, computational biology, and R&D.

The role requires diagnostic industry expertise and a successful track record launching molecular diagnostics in pharma partnerships and direct-to-clinic models, with global experience across US and international