Remote Senior Director, CDx Strategy & Precision Medicine

Regeneron Pharmaceuticals, Inc; United States; Remoto; USD 242.000 - 403.000; Tempo pieno

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is seeking a Senior Director of Companion Diagnostics (CDx) to set strategy and drive execution across a diverse portfolio.

You will lead a team, integrate diagnostic plans with clinical development, regulatory submissions, and patient access objectives, and influence across regulatory, translational, and commercial teams. You will translate biomarker hypotheses into target product profiles across platforms (NGS, PCR, IHC, immunoassays) and shape global regulatory

Competenze

• Advanced degree (PhD, MD, MD/PhD, or equivalent) in molecular biology, pathology, translational medicine, oncology, biomedical engineering, diagnostics, or a related scientific discipline.
• 12 or more years of experience in companion diagnostics, IVD development, biomarker strategy, or translational medicine within pharma, biotech, or diagnostics, including progressive leadership responsibility.
• Demonstrated 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 working knowledge of global CDx regulatory pathways, including FDA CDRH (PMA and supplemental submissions), EU IVDR, PMDA, performance studies, labeling, and post-approval obligations.
• Experience managing external diagnostic partners, IVD sponsors, central laboratories, CROs, and technology vendors within complex, timeline-sensitive programs.
• Proven people leadership, including mentoring talent, building capability, and setting priorities in a collaborative, accountable team environment.

Mansioni

• Set and lead global companion diagnostics strategy across the entire pipeline and all technologies, integrating diagnostic plans with clinical strategy, clinical development objectives & timelines, regulatory requirements, launch planning, and patient identification needs.
• Translate biomarker biology, mechanism-of-action hypotheses, clinical utility considerations into diagnostic target product profiles across relevant platforms, including NGS, PCR, immunohistochemistry, immunoassays, and emerging technologies.
• Define assay selection and development strategy from feasibility through analytical and clinical validation, regulatory submission, and post-approval lifecycle planning.
• Lead a team to successfully develop diagnostic strategies that support patient selection (and relevant exploratory datasets), stratification, monitoring, and evidence generation, accounting for timelines, cost, tissue requirements, turnaround time, reimbursement, global regulations and regional implementation.
• Provide executive oversight of external IVD sponsors, laboratory, and technology partner relationships, including partner selection, contracting strategy, governance, budgets, and escalation of critical issues.
• Accountable for operational readiness of CDx testing in clinical trials, including study startup, laboratory workflows, sample management, data transfer, and quality oversight.
• Shape global CDx regulatory strategy in partnership with Regulatory Affairs, including FDA, EU IVDR, PMDA, and other regional requirements, performance study design, submission content, labeling, and health authority interactions.
• Serve as senior CDx subject matter expert and strategic advisor to program teams and leadership, influencing decisions across translational medicine, clinical development, regulatory, biostatistics, clinical operations, commercial, medical affairs, market access, quality, and legal by communicating complex considerations clearly and credibly.

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is seeking a Senior Director of Companion Diagnostics (CDx) to set strategy and drive execution across a diverse portfolio.

You will lead a team, integrate diagnostic plans with clinical development, regulatory submissions, and patient access objectives, and influence across regulatory, translational, and commercial teams. You will translate biomarker hypotheses into target product profiles across platforms (NGS, PCR, IHC, immunoassays) and shape global regulatory