Senior Manager, Clinical Supply Operations
Regeneron Pharmaceuticals
Summary
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.
Job description
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.
- BS/BA degree in a related field.
- 8+ years of industry/relevant professional experience.
- 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
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.