Jobs / United States / Regeneron Pharmaceuticals INC
Senior Director, Clinical Diagnostics and Precision Medicine
Regeneron Pharmaceuticals INC · 🇺🇸 Remote - United States · Remote
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 290 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 40 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Regeneron Pharmaceuticals INC paid sponsored hires in similar roles4 certified filings for “Exec Medical Director Clinical Sciences” (Medical and Health Services Managers) in NY: $380k–$450k, median $415k. Most were filed at wage level IV (100%) — 4 lottery entries, ≈61% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Regeneron Pharmaceuticals INC
The US Department of Labor certified 290 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 40 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Regeneron Pharmaceuticals INC →
About the role
Build Our Future Together 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. You will lead a team of diagnostic professionals and are responsible for overall diagnostic (including CDx) strategies for the entire pipeline of therapeutic areas and across all technologies; partnering across Regeneron and with IVD partners to ensure diagnostic and therapeutic success. The role requires a leader who can translate biomarker hypotheses into fit-for-purpose diagnostic plans; guide assay selection, validation, and partner strategy; and influence across clinical, translational, regulatory, commercial, medical affairs, access, and external diagnostic organizations. When & where: • Location: Remote, USA • Work model/flexibility: Remote Discover your role: • 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. This role requires: • 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 pathw