Remote CDx Strategy Lead for Precision Medicine

Regeneron Pharmaceuticals; United States; Remote; USD 242.000 - 403.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals is seeking an accomplished companion diagnostics (CDx) leader to set strategy and drive execution across a portfolio of therapeutic programs and technologies, ensuring diagnostic plans align with clinical development, regulatory submission, and patient access.

You will lead a team of diagnostic professionals, influence across clinical, translational, regulatory, commercial groups, and manage external IVD partners to deliver CDx strategies from discovery through

Qualifikationen

• 12+ years in companion diagnostics, IVD development, biomarker strategy, or translational medicine with progressive leadership.
• Proven success leading CDx or biomarker-enabled diagnostic strategies through clinical development, regulatory submission, and therapeutic approval.
• Deep expertise in assay development, analytical and clinical validation, and clinical utility.
• Strong knowledge of global CDx regulatory pathways (FDA CDRH PMA, EU IVDR, PMDA).
• Experience managing external diagnostic partners, IVD sponsors, central labs, CROs, and vendors.
• Proven ability to mentor and lead teams in a collaborative, accountable environment.

Aufgaben

• Set and lead global CDx strategy across the pipeline and technologies, aligning with clinical strategy and regulatory timelines.
• Translate biomarker hypotheses into diagnostic target product profiles for various platforms (NGS, PCR, IHC, immunoassays).
• Define assay selection and development strategy from feasibility to validation and regulatory submission.
• Lead a team to develop CDx strategies for patient selection, stratification, monitoring, and evidence generation.
• Oversee external partner relationships, including selection, contracting, governance, and issue escalation.
• Ensure operational readiness of CDx testing in clinical trials, including sample management and data transfer.
• Shape global CDx regulatory strategy in partnership with Regulatory Affairs (FDA, EU IVDR, PMDA).
• Act as senior CDx SME and strategic advisor to program teams and leadership.

Kenntnisse

CDx leadership

Biomarker strategy

Regulatory knowledge

External partnerships

People leadership

Strategic planning

Ausbildung

Advanced degree (PhD/MD/MD-PhD)

Jobbeschreibung

Regeneron Pharmaceuticals is seeking an accomplished companion diagnostics (CDx) leader to set strategy and drive execution across a portfolio of therapeutic programs and technologies, ensuring diagnostic plans align with clinical development, regulatory submission, and patient access.

You will lead a team of diagnostic professionals, influence across clinical, translational, regulatory, commercial groups, and manage external IVD partners to deliver CDx strategies from discovery through