Senior Manager, Clinical Supply Chain

The Role:

We are seeking an experienced and talented individual who thrives in a dynamic, fast-paced, team-oriented, and collaborative environment. In this role, you will manage all aspects of the clinical drug supply chain, including forecasting, label creation/design, packing/labeling operations, clinical distribution management, and maintenance of the clinical drug supply strategy. You will collaborate closely with the internal clinical supply chain team, cross-functional team members and CMO/CRO/IRT vendors. As the Sr. Manager, Clinical Supply Chain, you will manage drug product label/pack/distribution at multiple CMOs and will contribute to IRT system development/implementation and maintenance to ensure uninterrupted drug supply for global clinical trials. 

This position will allow for growth within the role and the company, contributing your valuable experience in establishing policies and procedures for the Clinical Supply Chain department during a critical time. You will work closely with many cross-functional areas and will be able to contribute to their practices for a more efficient, cost-effective, and compliant clinical supply chain. Our fast-paced environment and hands-on opportunity will challenge you to innovate and learn while having fun with supportive and passionate colleagues. Join our team! 

Responsibilities:

• Support clinical supply activities for on-going and new clinical trials for on-time delivery, which includes demand forecasting, trial monitoring & resupply planning, IRT set-up and distribution activities at the program or compound level.
• Work with vendors to design IRT systems for new protocols and maintenance of existing ones, managing threshold levels, generation of manual shipments and disposition of quarantined materials, as needed. Organize role based UAT testing of IRT systems at kick off and system enhancements, as needed, based on protocol changes. 
• Generate supply forecasts and project plans to include clinical supply demand planning for all clinical supplies across all Nuvalent programs, working with internal Technical Operations on bulk GMP manufacture timing and quantities and Program Management for project milestones and goals. 
• Work collaboratively with Clinical Operations, Quality Assurance, CMC and Regulatory Affairs to efficiently deliver clinical supplies as needed while ensuring compliance to all applicable laws and
• Partner & build relationships with Clinical Research Organizations (CRO’s) for effective utilization of drug supply materials.
• Extensive vendor management, overseeing contributing third parties, clinical packagers, IRT vendors, distribution depots, etc. 
• Provide both program and protocol level leadership across all functional areas and levels of the
• Contribute with other Clinical Supply team members and other internal parties to develop department SOP’s and other strategic processes to enhance efficiencies and reduce costs. 
• Support and contribute to supply chain process initiatives driving improvements in demand planning, operational efficiency, cost, quality, and drug delivery.

Competencies:

• Excellent problem solving, communication and organization skills 
• Flexibility with changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks 
• Ability to work in a collaborative environment, drive to learn and improve skills 
• Ability to communicate salient regulatory concepts across the organization 
• Ability to strategically plan, organize and manage multiple projects simultaneously. 
• Ability to prioritize tasks/issues and identify risks in the future, raising awareness to potential issues in a proactive manner. Strong work ethic, ability to meet deadlines and flexible on the potential occasion you may need to work outside of immediate job role or normal job hours to get the task done and meet the deadline. 

 Qualifications:

• S./M.S. in a scientific field-or equivalent experience. Additional project management training/certification (PMP) would be beneficial.
• Seven (7)+ years of experience in managing multiple Phase 1-4 and IIS studies, including critical Phase 3 global clinical supply chains in the pharmaceutical and/or biotech industry, either as a sponsor, vendor or CRO.
• Experience with small molecule and familiarity with commercial supply chains in various global markets a plus. 
• Experience managing vendors with strong understanding of regulatory requirements and guidelines governing labeling, packaging and distribution of clinical trial materials US/EU/ROW/Japan and Global country requirements (FDA/EMA/ICH). 
• Knowledge of proper GMP/GXP trial documentation and familiarity with documents required to be stored in the Trial Master File (TMF) regarding clinical supply chain, IRT documents and drug supply source documents. 
• Cold chain product management, experience with forecasting tools, deep understanding of GMP/GXP requirements and development/implementation of sponsor internal processes & SOP’s for greater compliance and efficiencies. 
• Ability to creatively solve clinical supply chain issues. 
• Big picture understanding of the complete drug supply chain: Drug Substance/Drug Product/Regulatory Submissions and steps required for compliant drug release approvals and Global Importation logistics process. 
• Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, etc.), experience with automated applications (Excel, Word, PowerPoint, Project, etc.), experience with automated inventory systems, forecasting software and ERP Inventory management is a plus.