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Dir / Sr Dir, Clinical & Commercial Supply Chain

Full Time
74 E. Swedesford Rd, Suite 100, Malvern, PA, US
2 months ago | Requisiton ID:1039

The Director / Senior Director, Clinical & Commercial Supply Chain, reporting to the COO, will be primarily responsible for establishing robust and effective supply chains for the launch and sustained commercialization of Venatorx’s products.  He/She will a) provide clinical and commercial supply chain strategy, including the management and continual optimization of material inventories based on supply and demand, b) establish a robust commercial launch plan for new products with consideration of supply chain inputs such as  export / import requirements, tariffs and regulations, and overall cost of goods,  c) develop appropriate clinical and commercial supply chains through effective negotiation and management of vendors and management of internal staff d) be responsible for logistical operations to optimize quality, compliance, timelines and overall cost in development and commercialization.

 

 Duties:

  • Provides strategic leadership of clinical and commercial supply chain and demonstrates operational excellence to meet clinical and commercial supply chain deliverables.
  • Define commercial supply chains from API production through commercial distribution channels. Define manufacturing launch plans for Venatorx’s future commercial products. Evaluate 3PLs, serialization vendors and distributors to define commercial supply chain.
  • Collaborates with Clinical Operations, CMC, Quality Assurance, and Regulatory Functions to develop robust clinical supply strategy.
  • Develops and manages systems/reports for managing and communicating commercial and clinical supply chain status.
  • Coordinates packaging, labeling, and distribution of clinical supplies with vendors and internal stakeholders.
  • Leverage understanding of 3PLs, serialization vendors, export / import requirements, packaging & labeling, barcodes, serialization, testing on import, tariffs and regulations both in establishment of commercial supply chains and to support supply chain transactions across development and commercialization.
  • Establish best practices for Supplier Relationship Management. Optimize clinical and commercial supply chains for quality, compliance, timelines and overall cost while minimizing risk for the final stages of development and commercialization.  
  • Align the commercial forecasts with unit forecasts and market activities, creating an accurate demand signal for supply planning team/ plants in collaboration with stakeholders such as Production, Marketing, Finance, Business Development, Regulatory and Quality Operations
  • Reviews and contributes to clinical protocols (lead by Clinical Operations, input provided by Clinical Supplies on a need basis), clinical trial pharmacy manuals, packaging methods, packaging and labeling batch records, drug labels, shipping documents, destruction certification, and coordinate the origination, proofing and translation of clinical study labels and generation and updating with quality assurance all clinical supply related SOPs.
  • Ensure regulatory/ compliance requirements are met in clinical and commercial supply management.
  • Support contract negotiations and completion of commercial supply agreements and related contracts with requisite partners.
  • Partner to develop contract best practices to insure that all activities at external vendors are performed in compliance with Quality and EHS standards.
  • Insures that all needed studies are performed to support global shipping requirements and release of material in desired markets.
  • Actively participate and/or lead in stakeholders meetings to develop and implement strategy as well as ensure operational excellence is achieved.  
  • Contributes to the optimization of CMC development supply chains. 

 

Qualifications: 

  • Bachelor's degree with 12+ years of experience in the pharmaceutical/and or biotechnology industry in a supply chain planning/launch role.
  • PhD or Masters Degree with 7+ years of experience in the pharmaceutical/and or biotechnology industry in a supply chain planning/launch role.
  • Demonstrated clinical supply experience.
  • Experience in product launch and commercial CMC aspects of drug development e.g. Establishment of Supply Chain, Validation, shipping studies, import/export requirements, tariffs, etc.
  • Broad knowledge of CMO/CDMO, 3PL and distribution landscape
  • Knowledge of operational excellence and continuous improvement principles as applied to supply chain and manufacturing operations principles
  • Strong negotiation skills, broad understanding of business/financial acumen, excellent written/verbal communication, and effective problem-solving skills

 

 

                                                      Equal Employment Opportunity/M/F/disability/protected veteran status