Functieomschrijving
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.
You will own product vision, roadmap, and operations—balancing strategic planning with hands-on execution—while ensuring secure integrations, validated AI capabilities, and high levels of customer satisfaction.
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 8–10 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
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)