Strategic Leader, Precision Medicine & IVD

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

Benefits offered by this job

Performance bonuses

Equity participation

Comprehensive health benefits

Job summary

Precede Biosciences, Inc. is seeking an experienced strategic product leader to own the IVD product strategy for companion diagnostics and LDT products.

You will guide development through cross-functional collaboration with R&D, Translational Science, and Biopharma to translate clinical needs into robust product specifications and validation plans. The role demands deep expertise in NGS-based diagnostics, cfDNA biology, and regulatory pathways, with a track record of leading CDx partnerships and

Qualifications

• 10+ years of experience developing NGS-based IVDs, with at least 5 years in molecular diagnostics, oncology diagnostics, or precision medicine.
• Direct experience developing and launching diagnostic products through both LDT and companion diagnostic pathways.
• Experience collaborating with biopharma and academic partners to develop novel biomarkers and diagnostic solutions.

Responsibilities

• Develop and own IVD product strategy across companion diagnostics and LDT products and programs.
• Define clinical reporting strategy of biomarkers and the validation evidence required to enable clinical reporting.
• Lead the maturation and improvement of the IVD product development function with processes, frameworks, and best practices.
• Partner with R&D, Translational Science and Biopharma to translate customer needs into product specifications and acceptance criteria.

Skills

Strategic thinking

Cross-functional leadership

Communication skills

Data-driven decision making

Stakeholder management

Entrepreneurial mindset

Education

Advanced degree (PhD or MD) in life sciences

Job description

Precede Biosciences, Inc. is seeking an experienced strategic product leader to own the IVD product strategy for companion diagnostics and LDT products.

You will guide development through cross-functional collaboration with R&D, Translational Science, and Biopharma to translate clinical needs into robust product specifications and validation plans. The role demands deep expertise in NGS-based diagnostics, cfDNA biology, and regulatory pathways, with a track record of leading CDx partnerships and