[Hiring] Senior Director, Clinical Diagnostics and Precision Medicine @Regeneron Pharmaceuticals

Role Description

Regeneron is seeking an accomplished companion diagnostics (CDx) leader to set strategy and drive execution across a portfolio of therapeutic programs and technologies. As Senior Director, you will ensure that diagnostic strategies are integrated early and aligned with clinical development, regulatory submission, launch readiness, and patient access objectives.

• Lead a team of diagnostic professionals responsible for overall diagnostic (including CDx) strategies for the entire pipeline of therapeutic areas and across all technologies.
• Partner across Regeneron and with IVD partners to ensure diagnostic and therapeutic success.
• Translate biomarker hypotheses into fit-for-purpose diagnostic plans.
• Guide assay selection, validation, and partner strategy.
• Influence across clinical, translational, regulatory, commercial, medical affairs, access, and external diagnostic organizations.

Qualifications

• 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.

Requirements

• Set and lead global companion diagnostics strategy across the entire pipeline and all technologies.
• Integrate diagnostic plans with clinical strategy, clinical development objectives & timelines, regulatory requirements, launch planning, and patient identification needs.
• 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, stratification, monitoring, and evidence generation.
• Provide executive oversight of external IVD sponsors, laboratory, and technology partner relationships.
• Accountable for operational readiness of CDx testing in clinical trials.
• Shape global CDx regulatory strategy in partnership with Regulatory Affairs.
• Serve as senior CDx subject matter expert and strategic advisor to program teams and leadership.

Benefits

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits (e.g. medical, dental, vision, life and disability).
• Paid time off.
• Family support benefits.

Company Description

Regeneron is committed to building a workplace with an inclusive culture. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to any characteristic protected under applicable law.