Associate Director, Clinical Supply Chain

The Role:

Reporting to the Director, Clinical Supply Chain, the Associate Director, Clinical Supply Chain 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, collaborating closely with the internal clinical supply chain team, cross-functional team members and CMO/CRO/IRT vendors. The AD, Clinical Supply Chain 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, partnering across Nuvalent functions contributing to a most efficient, cost effective and compliant Clinical Supply Chain.

Responsibilities:

• Represent Clinical Supply Chain on the Clinical Study teams and other clinical related cross-functional meetings to ensure Clinical Trial Material supply milestones are met across all programs
• Support clinical demand activities for both on-going and new clinical trials. This includes demand forecasting, trial monitoring & resupply planning, label design, packaging vendor management activities, IRT set-up and distribution activities.
• Accountable for clinical labeling, packaging and distribution.
• Responsible for leading Clinical Supply Strategy Planning (CSSP) review meetings which captures CTM demands from Clinical Operations / Global Medical Affairs, reviews the bulk supply plan vs. aggregated clinical trial forecasts, addresses and mitigates program risks, and reviews current state of each protocol within a development program
• Will support the department budget including review & approval of vendor invoices, and monitoring planned vs. actual spend on both an assigned trial and program levels
• Develop root cause analysis and/or risk mitigation strategies and action plans to address any potential issues that may impact the integrity of the Clinical Supply Chain
• Provide leadership in the development and implementation of continuous improvement initiatives to improve lead-times, accelerate speed to customer, and reduce supply chain risks
• 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.  
• Lead and mentor Clinical supply managers

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 of potential issues in a proactive manner.
• Strong work ethic, ability to meet deadlines and flexibility on potential occasions you may need to work outside of immediate job role or normal job hours to get the task done and meet the deadline. 
• Comfort and ability to work in a fast-paced, rapidly changing environment.

Qualifications:

• S./M.S. in a scientific field-or equivalent experience. Additional Project Management Training (PMP) would be beneficial.
• Ten (10)+ 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 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. 
• Temperature 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, Smartsheet etc.), experience with automated inventory systems, forecasting software and ERP Inventory management is a plus.