Regeneron

Product Manager

• 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

Senior Manager, Product Management – Delivery & Operations

Risk

• Own and continuously evolve the governance framework to enable effective, scalable decision-making across the portfolio
• Establish and enforce decision quality and readiness standards, including clear articulation of options, trade-offs, risks, and recommendations
• Where required, facilitate governance forums to ensure structured, decision-focused discussions and clear, actionable outcomes
• Define and manage governance performance metrics (e.g., decision cycle time, right-first-time decisions, deferrals, forum utilization) to assess effectiveness
• Translate governance metrics and feedback into actionable insights, driving a closed-loop continuous improvement model
• Synthesize governance outputs into portfolio-level insights, identifying cross-program risks, recurring issues, and systemic bottlenecks
• Establish and maintain centralized decision documentation and knowledge management practices to ensure transparency and traceability
• Oversee governance intake, prioritization, and scheduling to ensure alignment to strategic importance, while advancing efficient, scalable processes and leveraging technology to streamline execution
• Drive cross-forum integration to streamline escalation pathways, eliminate duplication, and improve decision flow
• Partner closely with senior leaders, governance chairs, and stakeholders to align priorities and reinforce governance expectations
• Implement governance quality and experience measurement, incorporating multi-directional feedback from teams, executives, and chairs to improve effectiveness
• Coach and develop team members ensuring that the organizational strategy delivers the skills, capabilities and processes that enable portfolio delivery are present in his/her team

Director, Portfolio Governance

Financial Planning and Analysis

• Ensure compliance with financial requirements
• Maintain and develop guidelines for financial activities in Clinical Trials
• Execute financial controls in accordance with Company SOX requirements
• Partner with the Head of Program Finance for process changes/updates
• Facilitate Audit SOX annual reviews with auditors
• Provide mentorship on SOX key controls
• Perform ad-hoc reviews to detail budget control

Senior Financial Analyst

Operations

• Serves in a principal operational role for the Toxicology department
• Assists in defining standard departmental practices (including SOPs)
• Serves as the lead study monitor or sponsor representative
• Collaborates with lead scientists providing direct input on study designs and protocols
• Provides detailed evaluation of experimental data from Toxicology studies
• Assists/Directs the collection and evaluation of metrics associated with the conduct of Toxicology studies
• Provides toxicology leadership assistance in regulatory inspection readiness activities

Manager – Toxicology Operations

QA Engineer

• Guide and lead management of Good Clinical Practice Audit Strategy Programs
• Create strategic partnerships and direct risk-based audit activities
• Develop audit risk assessments and implement audit risk-based strategies
• Ensure audits are conducted in accordance with approved audit programs
• Maintain core study specific information for auditors
• Apply audit outcomes to identify quality trends and communicate compliance risks
• Represent on complex compliance projects
• Draft and issue periodic reports to management
• Provide education and/or training to Global Development departments

Manager, Quality Assurance – Good Clinical Practice, Auditor Strategy

Manager

• Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
• Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
• Provides input into baseline budget development and management
• Provides input into baseline timeline development and management
• Leads risk assessment and identifies risk mitigation strategies at the study level
• Leads the feasibility assessment to select relevant regions and countries for the study
• Monitors progress for site activation and monitoring visits and acts on any deviations from plan
• Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
• Monitors data entry and query resolution and acts on any deviations from agreed metrics
• Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
• Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
• May be assigned unmasked tasks for studies
• Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight

Senior Manager, Product Management – Delivery & Operations

Director, Portfolio Governance

Senior Financial Analyst

Manager – Toxicology Operations

Manager, Quality Assurance – Good Clinical Practice, Auditor Strategy

Senior Manager, Clinical Study Lead