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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 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.
#PrecisionMedicineCDX
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron , we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$242,000.00 - $403,300.00 Originally posted on Himalayas