Senior Manager, Clinical Supply Operations

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 134,000 - 219,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension benefits

401(k) match

Health & wellness

Fitness center

Insurance (medical, dental, vision)

Paid time off

Family benefits

Job summary

Regeneron Pharmaceuticals, Inc. in Warren, NJ is seeking a Senior Manager of Clinical Supply Operations to lead clinical supply activities and drive continuous improvements across logistics processes.

You will oversee CSO staff and coordinate with external vendors to ensure compliant, timely delivery of clinical trial supplies. The role demands strong leadership, extensive experience with clinical trials, GCP/ICH knowledge, and a track record in cross‑functional projects.

Qualifications

• Strong Leadership Skills.
• Experience working with external vendors.
• Experience leading cross functional projects/initiatives.
• Effective stakeholder management and negotiation skills.
• Ability to multi-task and adapt to changing priorities.
• Coaching and mentoring others.
• Knowledge of clinical trial methodology and GCP/ICH guidelines.
• Minimum: BS/BA degree in a related field.
• 8+ years of industry/relevant professional experience.

Responsibilities

• Oversee CSO activities and vendor oversight for clinical supply logistics.
• Lead cross-functional initiatives to optimize operational efficiency.
• Mentor and train CSO staff; manage TMF documentation.
• Develop and monitor performance metrics and analytics.

Skills

Leadership

Stakeholder management

Vendor management

Cross-functional collaboration

Coaching/Mentoring

GCP/ICH knowledge

Education

BS/BA degree

Masters/MBA/PharmD preferred

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.

Location

When & where: Primary Location: Warren, NJ

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.

Requirements

• 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: Masters/MBA/PharmD preferred with 8+ years of industry/relevant professional experience in the following fields: Clinical Supplies QA/Regulatory Precision Medicine Supply Chain Manufacturing Or equivalent research/commercial biopharma experience

Benefits

• 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
• family support benefits

Salary Range (annually) $134,400.00 - $219,200.00

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 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.

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.

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.