Project Manager Ivdr Jobs (NOW HIRING)

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Clinical Diagnostics to support end-to-end companion diagnostics (CDx) strategy and execution across our therapeutic indications. In this role, you will translate scientific needs into fit-for-purpose assays for global decisions, owning programs from feasibility through validation, registration, launch, and post-market sustainment, while partnering with biomarker, clinical, regulatory, commercial, and IVD collaborators.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Tarrytown, NY

• Work model/flexibility: Onsite

• Travel percentage: Up to 5-10% for partner meetings, clinical site visits, and regulatory interactions.

Discover your role:

• Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines

• Lead cross-functional teams, integrate workstreams, clear obstacles, and provide transparent status reporting to governance bodies and senior leadership

• Manage IVD partners, negotiating scope, timelines, budgets, and quality, and overseeing co-development and Joint Steering Committees

• Define assay intent and contribute to target product profiles for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays), driving analytical and clinical validation

• Embed CDx assays in trials with clinical teams, covering screening/stratification, sampling, site readiness, and lab operations

• Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs, labeling, and responses

• Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI, IVDR, GCP), maintaining documentation and audit readiness

• Thrive in a fast-paced, multi-tasking environment, bringing strong communication skills to cross-functional collaboration.

This role requires:

• Advanced degree in molecular biology, pathology, biomedical engineering, or equivalent experience

• 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs in pharma or diagnostics organizations

• Proven delivery of CDx aligned to drug approvals, with successful validation and regulatory submissions

• Expertise in NGS, PCR, IHC, and immunoassays, along with validation standards and quality systems

• Strong grasp of global regulatory pathways (FDA CDRH, EU IVDR, PMDA) for CDx labeling

• Excellent communication, leadership, and stakeholder management skills, with the ability to deliver clear updates to executive audiences

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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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)