Senior Manager, Clinical Supply Operations

Regeneron Pharmaceuticals•Warren, MI

2d•$134,400 - $219,200•Onsite

About The Position

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.

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.

Nice To Haves

Masters/MBA/PharmD preferred
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

Responsibilities

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.
Leverage logistics performance metrics, identify risks and implement 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.
Mentor and train others to obtain quality results.
Lead, coach, and mentor 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.
Manage and lead 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.