Senior Manager, Clinical Supply Operations

Regeneron Pharmaceuticals, Inc.; New Jersey; On-site; USD 150,000 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Supply Operations in Warren, NJ. You will lead clinical supply activities, oversee vendor performance, and drive continuous improvement across Clinical Supply processes.

You will mentor CSO staff, manage IP activities and TMF documentation, and partner with cross-functional teams to optimize operations and enable timely, compliant clinical trial supply. Strong leadership and regulatory knowledge are essential.

Qualifications

• BS/BA degree in a related field.
• 8+ years of industry/relevant professional experience.
• Masters/MBA/PharmD preferred with 8+ years in Clinical Supplies/QA/Regulatory/Supply Chain.

Responsibilities

• Vendor oversight and operational support for distribution vendors.
• Collaborate with cross-functional partners to enhance Clinical Supply Operations processes.
• Represent CSO needs in cross-functional discussions and drive change management.

Skills

Vendor oversight

Cross-functional collaboration

Project management

Data-driven decisions

Mentoring & coaching

Regulatory knowledge (GCP/ICH)

Operational leadership

Communication

Education

BS/BA degree in a related field

Masters/MBA/PharmD preferred

Tools

TMF knowledge

Job description

Senior Manager, Clinical Supply Operations

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.
• 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.
• 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:

• 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:

Masters/MBA/PharmD preferred with 8+ years of industry/relevant professional experience in the following fields:

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

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 reassignment, 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.

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.