Regeneron
Associate Director, Vendor & Relationship Management
Regeneron, Basking Ridge, New Jersey, us, 07920
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 delivery to plan – time, budget, quality. Develop/enhance vendor performance scorecards that drive 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 a 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 judgment and decision-making. May require up to 25% travel. Requires a minimum of 3 days on-site in Basking Ridge, NJ or Armonk, NY. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 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) $151,800.00 - $247,800.00
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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 delivery to plan – time, budget, quality. Develop/enhance vendor performance scorecards that drive 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 a 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 judgment and decision-making. May require up to 25% travel. Requires a minimum of 3 days on-site in Basking Ridge, NJ or Armonk, NY. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 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) $151,800.00 - $247,800.00
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