The Associate Director, Vendor Management, is responsible for assessing, onboarding, and overseeing the health and performance of vendors involved in clinical trial execution. This role ensures that vendors meet the necessary qualifications and compliance standards, manage relationships, and oversee delivery to time, cost, and quality. This position is capable of leadership and oversight of vendor segments, and of the technical aspects such as quality, compliance, business continuity, and inspection readiness.

This position is expected to have the ability to execute a variety of roles to meet the expectations of effective relationship management and driving compliance and high-quality delivery.  

Relationship Management

• Oversee the performance and health of vendors within assigned segment to ensure deliver to plan – time, budget quality.

• Develop/enhance vendor performance scorecards that drives identification of mitigations/contingencies against performance risks/issues

• Build and maintain strong relationships with key vendors.

• Act as the primary point of contact for relationship level vendor-related issues and escalations. 

• Assess portfolio resource demand and shortfall/mitigations for current and potential future portfolio with key vendors

• Lead the integration of new vendors into Regeneron strategy and operating model(s) to create stronger probability of success with new collaborations

Leadership

• Mentor and develop team members, fostering a culture of continuous improvement.

• Collaborate with cross-functional teams to ensure cohesive vendor management practices.

• Engage with Development Services and Operational Excellence’s (DSOE) Change Management function to facilitate process change, stakeholder readiness and communication strategy as required.

• May have direct supervision over support staff. 

Quality and Compliance Oversight:

• Ensure vendors comply with regulatory requirements and organizational standards, including proper documentation of partnerships is developed and maintained.

• Conduct regular quality and compliance assessments of vendors.

• Develop and implement corrective action plans for any identified issues.

• Lead relevant governance meetings on behalf of Regeneron including agendas, minutes, and timely follow-up of action items

Vendor Qualification and Business Continuity:

• Develop and/or manage against business continuity plans involving vendors.

• Conduct regular reviews and updates of business continuity plans.

• Ensure minimal disruption in clinical trial operations through effective continuity planning.

• Contribute to the Qualification process, with a steady focus on continuous improvement and stakeholder management

Inspection Readiness and Support:

• Ensure vendors are prepared for regulatory inspections and applicable audits.

• Coordinate and support inspection activities, including pre-inspection preparation and post-inspection follow-up.

• Maintain inspection readiness documentation and records.

Vendor Management Operations, where applicable:

• Lead and facilitate the conduct of the internal governance bodies related to sourcing strategy and operating models 

• Accountable for continuous assessment of capacity management for external resources 

• Lead the integration of new processes and/or changes to process across applicable vendors

To be considered you must have a Bachelor’s degree required with 10+ years in pharma industry, specifically in operations and/or vendor management discipline. Minimum of 10 years of experience and success in a clinical project/ trial management role within biotech/pharmaceutical industry. Strong knowledge of GCP, FDA, EMA, and other relevant regulatory requirements. Highly collaborative with strong written and verbal communication skills; effective customer focus; ability to interact with all levels of employees and maintain confidentiality. High aptitude and competency with Microsoft Office along with new/emerging technical solutions. Excellent organizational and project management skills. Strong communication and interpersonal skills. Ability to work independently and as part of a team. Self-starter who takes initiative and can handle risk and uncertainty. Ability to work in a fast-paced environment and manage multiple priorities. Able to exercise sound judgement and decision making. May require up to 25% travel. Requires minimum of 3 days on-site in Basking Ridge, NJ or Armonk, NY.