Senior Manager/Associate Director, Clinical Supply Chain (Remote EU)
Odonate Therapeutics, Inc.
 Boston, MA

Position Summary

The Senior Manager/Associate Director, Clinical Supply Chain will oversee operations including clinical packaging, labeling and distribution, and will help manage the global supply network and associated inventories to support patients worldwide. This individual will be responsible for the regional management of Contract Manufacturing Organizations (CMOs), depots and distributors in Europe which requires negotiations, relationship management and financial oversight and the ability to address any site-level drug supply related inquiries. This position will closely interface with Clinical Operations, Manufacturing, Quality Assurance, Product Development, Regulatory Operations and IRT partners to ensure clinical material is available (as required) and clinical trial strategies and timelines are adhered to.

Essential Duties and Responsibilities

  • Provide site-level support within the assigned region (i.e. temperature excursion management, supply shortage, damaged shipment, IRT resolution)
  • Provide regional oversight of CMO/depots including packaging and labeling operations, comparator sourcing, logistics and CMO/depot setup
  • Manage the label design process form master text to proof aligned with regulatory submission requirements and packaging/labelling strategies for global studies
  • Maintain budget for regional supply chain operations
  • Help execute a multi-stage regional/global inventory plan for bright stock and finished goods in coordination with Manufacturing, Clinical Operations, Commercial Operations and Quality Assurance
  • Ensure batch release dates are properly prioritized for manufacturing, packaging and labeling timelines based on input from Clinical Operations, Manufacturing, Regulatory and Quality
  • Understand and create strategies related to CMC changes on a by country basis through IND/IMPD/nIMPD process, ensuring necessary controls at CMO/depots
  • Help develop and formally document clinical supply strategies and processes
  • Support international depot vendor selection process, obtaining RFPs, establishing competitive bids and negotiation of agreements when needed
  • Onboard and manage relationships with international depot vendors, including the establishment of agreements, quotes, purchase orders and invoicing
  • Manage inventory reconciliation and partner with Finance for financial closes
  • Maintain oversight of owned contracts through quarterly business review and metrics collection/analysis
  • Compile and load required documents to the Trial Master File (TMF)
  • Develop and report metrics and required information through department reporting tools
  • Ensure supply chain compliance to GCP documentation requirements and training
  • Help establish consistent supply strategies across product lines and compliance with company policies, procedures and applicable regulatory authority directives and regulations
  • Establish clear communication and tracking of strategies and scenarios for project teams and senior management
  • Create and maintain Supply Chain related Standard Operating Procedures (SOPs)
  • Facilitate group trainings involving initiatives by FDA, EMA and other applicable regulatory authorities related to Supply Chain and documentation
  • Provide oversight for importation/exportation compliance of labeled supplies to the appropriate drug depot and subsequent shipment to the clinical sites
  • Participate in inspection readiness efforts, ensuring Supply Chain is fully prepared for both internal and external audits
  • Help track Supply Chain change controls, deviations and CAPAs, and work to resolve recurring problems with permanent solutions
  • Leverage controlled room temperature and cold chain expertise to guide selection of shippers, couriers and shipping lanes

Qualifications

  • Bachelor's Degree in Supply Chain or related discipline required
  • Minimum 10 years of experience in supply management and logistics within bio-pharmaceutical industry required
  • Minimum 5 years of management experience required
  • Must be based in EU or United Kingdom
  • Proficient in cGMP's and pharmaceutical industry procedures and regulations
  • Expert in supply and depot management globally
  • Understanding of systems selection, design and management
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
  • Strong organizational skills with the ability to manage projects, resources, timelines and budgets, in a fast-paced, entrepreneurial environment
  • Ability to effectively engage and influence internal and external leaders, solicit information, persuade others and shape outcomes
  • Strong interpersonal skills and the ability to lead a team
  • Problem-solving and decision-making skills
  • Demonstrated ability for analytical and systematic thinking
  • Must be proficient in Microsoft Word, Excel, PowerPoint and Project