Senior Manager, Clinical Supply Operations

BioSpace; New Jersey; On-site; USD 134,000 - 219,000; Full time

Job summary

Regeneron is seeking a Senior Manager of Clinical Supply Operations to lead CSO activities and oversee clinical supply logistics for trials in Warren, NJ. This role focuses on vendor oversight, process improvement, and staff management to ensure compliant supply operations.

You will mentor CSO staff, collaborate with cross-functional teams, and drive data-informed improvements while maintaining GCP/ICH standards.

Qualifications

• BS/BA degree required; 8+ years of relevant experience.
• Masters/MBA/PharmD preferred with 8+ years in Clinical Supply/biopharma.

Responsibilities

• Vendor oversight and performance monitoring for Clinical Supply Vendors.
• Lead and support departmental initiatives to improve Clinical Supply Operational processes.
• Mentor and develop CSO staff; manage IP activities and TMF documentation.

Skills

Leadership

Vendor management

Cross-functional collaboration

Stakeholder management

Mentoring

Project management

Clinical trial methodology

GCP knowledge

ICH guidelines

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.

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 CDSLs 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

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

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.

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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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