Senior Manager, Clinical Supply Operations

Regeneron Pharmaceuticals; Warren (MI); On-site; USD 134,000 - 219,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Senior Manager of Clinical Supply Operations to lead CSO activities supporting clinical supply logistics and vendor oversight. You will drive improvements, mentor staff, and manage TMF documentation for IP activities, ensuring compliance with GCP and ICH guidelines.

This on-site role in Warren, NJ requires strong leadership and cross-functional collaboration. Qualified candidates will have BS/BA in a related field and 8+ years of industry experience, with

Qualifications

• BS/BA in a related field required.
• 8+ years of industry/professional experience preferred.
• Experience with clinical supply and regulatory processes is a plus.

Responsibilities

• Oversee distribution vendor oversight and monitor performance against policies and procedures.
• Collaborate with cross-functional partners to enhance Clinical Supply Operational processes.
• Advise CSO team on tasks, projects, and initiatives; mentor and train others.

Skills

Leadership

Communication

Vendor management

Cross-functional collaboration

Stakeholder management

Mentoring

Multi-tasking

Clinical trial knowledge

GCP/ICH knowledge

Education

BS/BA degree in a related field

Job description

Build our future together:

The Senior Manager of Clinical Supply Operations is a key member of the Clinical Supply Operations Team, whose primary responsibility is leading Clinical Supply activities that support the development and operation of Clinical Supply Logistics processes. This position plays a key role in the operational oversight of Clinical Logistics Vendors and Clinical Supply processes, identifying areas of improvement, and driving continuous improvements, while leveraging data driven insights. The Senior Manager is responsible for managing CSO staff members.

When & where:

• Primary Location: Warren, NJ

Discover your role:

Vendor Oversight and Operational Support:

• Manage and/or support distribution vendor oversight activities by acting as point of escalation for CDSL and monitor their performance against expectations and according to established policies and procedures. Leverages logistics performance metrics, identifies risks and implements remediation steps in partnership with our Vendors to ensure CDSL’s concerns are addressed.

Departmental Leadership:

• Collaborate with cross functional partners to develop and enhance Clinical Supply Operational processes to ensure delivery of Clinical Trail Supply
• Represent the needs of Clinical Supply Operations at cross functional discussions/initiatives and be a champion of change management.
• Act as advisor to Clinical Supply Operations team members on operational tasks, process issues, projects, and initiatives. Mentors and trains others to obtain quality results.

Supervising:

• Leads, coaches, and mentors CSO Specialists in the execution of IP activities (i.e. release, shipment, temperature excursion management, returns, reconciliation, and destruction) and maintenance of TMF documentation to support clinical studies.

Continuous Improvement:

• Lead cross functional improvement initiatives to optimize operational efficiencies and support strategic decision-making/problem-solving.
• Manages and leads strategic and operational standardization, analytics and continuous improvement.
• Create and manage performance metrics to provide visibility to operational performance, insights, trends, and identify areas of opportunity.

This role requires:

• Strong Leadership Skills

• Ability to effectively communicate across an organization.

• Experience working with external vendors.

• Experience leading cross functional projects/initiatives.

• Effective stakeholder management, influence and negotiation skills.

• Ability to effectively multi-task and adapt to changing priorities.

• Experiencing coaching and mentoring others.

• Working knowledge of clinical trial methodology.

• Working knowledge of GCP and ICH Guidelines.

Minimum:

BS/BA degree in a related field. 8+ years of industry/relevant professional experience.

Preferred:

• Clinical Supplies
• QA/Regulatory
• Precision Medicine
• Supply Chain
• Manufacturing

Or equivalent research/commercial biopharma experience

Does this sound like you? We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignement, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$134,400.00 - $219,200.00