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.

• Primary
  
  Location:
  
  Warren, NJ

• 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.

• 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.

• 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

Does this sound like you? 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…