RegeneronAssociate Director, Clinical Diagnostics
This role provides an exciting opportunity to lead projects across diverse therapeutic areas. As the Associate Director, Clinical Diagnostics (CDx), you will own the end-to-end strategy, development, and lifecycle management of companion diagnostic solutions that enable our therapeutics. This role drives cross-functional alignment across biomarker science, clinical development, regulatory, commercial, and external IVD partners to deliver fit-for-purpose assays that meet global regulatory requirements and support clinical decision-making. You will lead the CDx portfolio from early biomarker feasibility through clinical validation, registration, launch, and post-market sustainment, ensuring timely availability of high-quality diagnostics aligned with drug development milestones.
A typical day might include:
Set the global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines for the therapeutic.
Lead selection and oversight of IVD partners; negotiate scopes, timelines, budgets, and quality expectations; manage co-development and governance.
Define assay intent and target product profiles (TPP) for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays), ensuring analytical and clinical performance meets intended use.
Partner with biomarker and clinical teams to integrate CDx into trial designs (screening, enrichment, stratification), including sample strategy and operational readiness.
Drive analytical validation plans (e.g., accuracy, precision, sensitivity/specificity, LoD, reproducibility) and clinical validation strategies linking assay results to drug safety and efficacy.
In collaboration with IVD Regulatory, support global regulatory strategy and submissions for CDx (e.g., FDA PMA/supplement, 510(k) where applicable, EU IVDR, PMDA), including pre-submission interactions and labeling alignment.
Ensure compliance with applicable standards and regulations (e.g., ISO 13485, ISO 14971, CLSI guidelines, IVDR, GCP alignment for diagnostic use in trials).
Coordinate cross-functional working groups, remove program obstacles, and provide transparent status reporting to governance bodies.
Oversee design transfer, manufacturing readiness, and supply planning with IVD partners to ensure clinical and commercial availability.
Drive risk management and mitigation plans across technical, regulatory, operational, and commercial domains.
Partner with commercial and medical affairs to shape CDx launch readiness (access, coverage, distribution, training, KOL engagement).
This role might be for you if:
Proven track record delivering CDx aligned to drug approvals, including successful analytical/clinical validation and regulatory submissions.
Deep understanding of diagnostic platforms (NGS, PCR, IHC, Immunoassays) and associated validation standards and quality systems.
Experience managing external IVD partners and complex, cross-functional programs.
Strong knowledge of global regulations (FDA CDRH, EU IVDR, PMDA) and pathways for CDx approval and labeling.
Excellent communication, leadership, and stakeholder management skills.
Strategic thinking with the ability to translate scientific and clinical needs into executable diagnostic solutions.
Program leadership, planning, and risk management across multiple, fast-paced workstreams.
To be considered for this position, you must have:
Advanced degree in a relevant field (e.g., MS/PhD in molecular biology, pathology, biomedical engineering, or related) or equivalent experience.
8+ years of experience in diagnostics development, with 4+ years leading CDx or IVD programs in pharmaceutical or diagnostics settings
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 have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$176,100.00 - $287,300.00