Cdx Diagnostics Jobs (NOW HIRING)

As Senior Manager, Clinical Diagnostics, you will support end-to-end CDx strategy and execution to enable therapeutics across indications. Partnering with biomarker, clinical, regulatory, commercial, and IVD collaborators, you will translate scientific needs into fit-for-purpose assays for global decisions. You will own programs from feasibility through analytical/clinical validation, registration, launch, and post-market sustainment, ensuring timelines, quality, and budgets aligned to drug milestones. This role combines hands-on leadership, vendor management, and cross-functional orchestration under quality and regulatory frameworks. You will serve as a governance interface and refine CDx strategy.

As a Senior Manager, a typical day may include:

• Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines for seamless program delivery.

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

• Manage IVD partners-negotiate scope, timelines, budgets, and quality; oversee co-development, Joint Steering Committees, and performance.

• Define assay intent and contribute to target product profiles (TPP) for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays); drive analytical validation (accuracy, precision, sensitivity, specificity, LoD, reproducibility) and clinical validation linking performance to benefit-risk.

• Embed CDx assays in trials with clinical teams-screening/stratification, sampling, site readiness, and lab operations for reliable execution.

• Partner with IVD Regulatory on global submissions-FDA PMA/supplements, 510(k) as applicable, EU IVDR, PMDA; support pre-subs, labeling, and responses.

• Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP; maintain documentation, audit readiness, and proactive, integrated risk management.

• Oversee design transfer, manufacturing readiness, and supply; support launch readiness with Commercial/Medical teams.

This role may be for you if:

• You thrive in a fast-paced environment

• You are detail oriented, well-organized and can multi-task

• You are a team player

• You have strong communication skills

To be considered for this role, you must have

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

• 4+ years in diagnostics development; 2+ years leading CDx/IVD in pharma or diagnostics organizations.

• Proven delivery of CDx aligned to drug approvals; successful validation and regulatory submissions.

• Expertise in NGS, PCR, IHC, immunoassays; validation standards and robust quality systems.

• Strategic thinking with the ability to translate scientific and clinical needs into executable diagnostic solutions.

• Strong grasp of global FDA CDRH, EU IVDR, PMDA pathways for CDx labeling.

• Excellent communication, leadership, and stakeholder management; clear, concise updates to executive audiences.

• Strategic translation of scientific and clinical needs into executable diagnostics under QMS/GxP.

Travel:

Travel up to 5-10% for partner meetings, clinical site visits, and regulatory interactions

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)