Director Site Budgets & Contracts

The Director of Site Budgets & Contracts (Medical Affairs) is responsible for leadership of the team of Site Contracts Leads (SCLs) who are responsible for (1) developing and negotiating global investigator-initiated study (“IIS”), compassionate use, research collaboration, and Regeneron sponsored Phase IV non-interventional studies (i.e., patient registries) budgets and contracts, (2) reviewing sites’ proposed changes to standard contract terms and the study-specific budget parameters (in partnership with other business lines internally), (3) ensuring the delivery of high quality, compliant, effective, and timely site contracts, (4) maintaining productive relationships with internal client groups and sites, and (5) participating in ongoing process improvements. The Director is accountable for leading, managing, coaching, training, and onboarding direct reports. This individual is responsible for managing the global operational model, including internal and vendor staff who are responsible for conducting site contract negotiations. The Director of Site Contracts interacts with cross-stakeholder, senior level management, external vendors, and collaboration partners.

Job Duties:

• Think strategically about Regeneron’s ideal approaches to conducting site contracting and drive solutions, while ensuring compliance

• Manage the contracting operational model for assigned areas, which includes a combination of in-house v. outsourced negotiations

• Partner with colleagues in the Law Department and other stakeholder groups, as needed, to continuously enhance the operational model and prioritize assignments across assigned therapeutic areas

• Maintain key site contracting metrics for vendors and direct reports, ensure that internal systems are updated in a timely, accurate, and complete manner, and maintain an overview of contract statuses and issues, in order to proactively communicate progress, risks, issues or changes that may impact quality, timelines and/or budget

• Acts as a point of contact for contract escalations

• Provides innovative and flexible operational solutions and options and proactively creates and implements risk mitigation strategies

• Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects

• Ensures inspection readiness throughout the clinical program lifecycle

• Act as the single point of accountability for ensuring that direct reports are meeting performance and efficiency standards and performing in a manger that is consistent with Regeneron’s values

• Responsible for ensuring the delivery of high quality, compliant, effective, and timely work product; line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight

• Ensure that staff is engaged closely with internal client groups, sites, and various stakeholders and effectively communicating with them, in order to ensure that business objectives are met

• Ensure that vendors and staff are conducting issue resolution of moderate to high complexity

• Establish team goals that will increase knowledge and skill level (delegate tasks accordingly, commensurate with skill level)

• Accountable for ensuring consistency of process and approaches across studies

• Helps drive decision making and integrates all operational considerations for studies to ensure that contract finalization goals are attainable prior to implementation

• Directly accountable for the day-to-day management of the applicable vendors across the portfolio, in partnership with Medical Affairs, Strategic Sourcing & Procurement, Law Department, and Vendor Management colleagues

• Manage metrics and ensure that our KPIs are met

• Handle site contracting related escalations effectively and efficiently

• Train the CRO’s staff on our templates, tools, and processes and drive compliance, best-in-class quality, and speed

• Assist with internal and external resource forecasting and allocation activities

Job Requirements:

• Applies expert-level understanding of global site contract negotiations and advanced interpersonal and communication skills

• Decisions have short and long-term impact on department schedules, quality, compliance, and resource allocation

• Significant influence on department and staff. Results/performance have direct impact on costs, objectives, and overall group

• Helps establish operational objectives and work plans, delegating assignments to subordinate staff

• Provides leadership with input about departmental strategy, organizational goals, and current policies

• Applies advanced interpersonal, communication, influencing, and problem-solving skills

• Ability to mitigate and drive solutions regarding investigator site budget and contract negotiation challenges

• Ability to provide strategic direction and guidance for assigned book of work

• Analytical skills with a data driven approach to planning, executing, and problem solving

• Budget management experience

• Ability to build, train, manage, and coach high performance and growth teams

• Extensive experience in global clinical site negotiation

• May require up to 25% of broader travel

• Minimum of 10 years of direct experience with global Phase 2-4 clinical site contract negotiations (preferably including IIS and research collaboration clinical site negotiations) at a biopharmaceutical company or CRO required, including strong ex-U.S. site negotiation experience

• Minimum of 8 years of people management and global site contracting experience required

• Minimum of 5 years of experience working with a vendor for global outsourced clinical site contracting

• Cross-therapeutic area experience required (e.g., oncology, hematology, general medicine, and internal medicine)