Product Lead, Delivery & Operations

The Delivery & Operations Product Lead (Senior Manager) drives end-to-end delivery, support, and optimization of a Global Development technology product focused on standards-led protocol digitization, biospecimen lifecycle management, and AI-enabled orchestration. Partnering with process owners, IT teams, and vendors, the role turns ICH M11/USDM and CDISC standards into reusable digital assets that power Digital Data Flow (DDF) and improve study build speed, data quality, and regulatory compliance. In this role, a typical day might include the following: Leading agile ceremonies, refining backlogs, and approving user stories for protocol-to-data and sample-workflow features Facilitating workshops with clinical, biometrics, and lab SMEs to gather requirements and prioritize improvements Reviewing architecture and validation plans to ensure security, privacy, and GxP compliance for API and AI components Supervising platform usage, data-quality dashboards, and AI guardrail metrics to drive continuous improvement Managing vendor results, budgets, and risks while preparing executive-ready status updates Coordinating change, release, and incident processes to maintain audit-ready, high-performing operations This Job Might Be For You If You Translate complex protocol, biospecimen, and standards concepts into intuitive digital products Enjoy orchestrating multi-system integrations (EDC, LIMS, IRT, CTMS) and ensuring traceable data lineage Thrive in fast-paced, agile environments and can balance strategic goals with day-to-day execution Communicate clearly with executives and engineers alike, influencing without direct authority Stay current on AI/agentic and CDISC 360 trends and apply them pragmatically in regulated settings Possess a get-it-done attitude, solving issues quickly while keeping long-term value in focus In order to be considered for this role, you must have: BS/BA with 810 years (or MS with 6+ years) in Global Development IT, including protocol digitization, biospecimen workflows, and standards (ICH M11/USDM, CDISC SDTM/ADaM) Consistent track record delivering GxP-validated, AI-enabled products with integrations across EDC, LIMS, and analytics platforms Deep experience in agile product management, vendor oversight, and regulated change/validation processes 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. Benefits 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 family support benefits We believe our best work happens together. Many roles are required to be performed onsite. Please speak with your 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) $134,400.00 - $219,200.00 #J-18808-Ljbffr BioSpace