Remote Senior Director, CDx Strategy & Precision Medicine

BioSpace; United States; Remote; USD 242,000 - 403,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron is seeking a Senior Director of Companion Diagnostics to set strategy and drive execution across a broad therapeutic portfolio. You will lead a team of diagnostic professionals and ensure diagnostic plans align with clinical development, regulatory submission, and patient access goals.

You will translate biomarker hypotheses into fit-for-purpose diagnostic plans across platforms, define assay development strategy, and oversee external partnerships and regulatory strategy globally.

Qualifications

• Advanced degree with strong background in molecular biology, pathology or translational medicine.
• 12+ years in CDx/IVD development and biomarker strategy.
• Proven leadership in biomarker-enabled diagnostics through development and approval.

Responsibilities

• Set and lead global CDx strategy across the pipeline across technologies.
• Translate biomarker biology into diagnostic target profiles for platforms (NGS, PCR, IHC, immunoassays).
• Define assay development strategy from feasibility to validation and regulatory submission.
• Lead a team to develop diagnostic strategies for patient selection, stratification and evidence generation.
• Provide executive oversight of external IVD sponsors and partner relationships.
• Oversee operational readiness of CDx testing in clinical trials including sample management and data transfer.
• Shape global CDx regulatory strategy with Regulatory Affairs across FDA/EU PMA/IVDR/PMDA.
• Act as senior CDx SME to program teams and leadership.

Skills

CDx leadership experience

Biomarker strategy

Global regulatory knowledge

People leadership

Education

PhD/MD/MD-PhD or equivalent in related field

Job description

Regeneron is seeking a Senior Director of Companion Diagnostics to set strategy and drive execution across a broad therapeutic portfolio. You will lead a team of diagnostic professionals and ensure diagnostic plans align with clinical development, regulatory submission, and patient access goals.

You will translate biomarker hypotheses into fit-for-purpose diagnostic plans across platforms, define assay development strategy, and oversee external partnerships and regulatory strategy globally.