Director, Clinical Supply Chain

Summary

Join Verona Pharma as their Director, Clinical Supply Chain, reporting to the Sr Director, CMC. You will be responsible for the strategic planning and execution of clinical program supply chains, interpreting clinical trial protocol designs, and advising on supply-related matters. Collaboration with various teams (Clinical Operations, Regulatory Affairs, Quality Assurance, CROs, and CDMOs) is crucial. Remote work flexibility is offered, but some on-site presence in the Raleigh/Durham/Chapel Hill area is required. Success requires applying best practices in project management and building strong cross-functional relationships. Verona Pharma offers a competitive benefits package, including generous PTO.

Requirements

• Have a Bachelor’s Degree (science or business degree preferred)
• Have at least 10 years’ experience in Clinical Supply Chain Management within pharmaceutical/biotech, CMO or CRO Organizations
• Have extensive experience in clinical forecasting including the ability to translate complex clinical trial designs into demand forecasts and supply plans
• Have a deep understanding of supply chain networks, IRT, GXP, Quality (GMP/GCP), clinical regulations with respect to IP in a pharmaceutical/biotech R&D environment
• Have a deep understanding of the IP and Medical Devices, be a Subject Matter Expert on Pharmacy, and dosing aspects of the IP
• Have the ability to develop new ways of working and the creativity to aid in establishing robust business processes
• Have the ability to successfully build trust and influence across all levels internally and externally
• Have the ability to develop solutions for diverse and complex supply chain issues simultaneously for multiple studies
• Have the ability to make forecasting decisions that align work with organizational priorities, even in ambiguous situations
• Have vendor selection process and management, and budget management experience
• Have flexibility regarding schedule and work projects
• Have strong Microsoft Office skills (Word, Excel, PowerPoint, Project etc.)
• Have the ability and willingness to travel 10-15%, including domestic and international

Responsibilities

• Lead and be responsible for the planning and execution of clinical supply requirements for the clinical program, ensuring timely API and drug product manufacture, packaging, labeling, and distribution of clinical supplies for global clinical studies
• Act as a key interface with Clinical, CMC, Regulatory, and CRO teams and contribute to study protocol design, approving pack design and defining distribution strategy, as a member of the clinical development matrix team
• Be responsible for forecasting, planning, and contingency planning to ensure the provisions of clinical supplies for clinical studies in collaboration with Clinical, CMC, Regulatory, and CRO teams and in alignment with clinical study timelines
• Be responsible for clinical supply chain project management to ensure, in collaboration with CMC and CDMO colleagues, procurement and management of supply inventory, vendor oversight and management, shipping & receiving
• Execute high-quality, integrated cross-functional plans for the management of clinical study supplies. Be a key stakeholder in clinical study supplies vendor selection process and accounting for supplier/vendor-related relationship management; serve as a point of escalation for vendor performance issues, internal customers, and cross-functional partners; act as a point of contact for clinical supply requirements
• Interact collaboratively across internal company departments and external manufacturing, packaging, and labeling Contract Development Manufacturing Organizations (CDMOs)
• Design and present program-level forecasts and demand plans to members of Senior Management embracing investigational product, comparators, and ancillaries, as appropriate
• Author Investigational Product Handling and Pharmacy Manuals, providing key drug supply and ancillary handling information
• Contribute to Regulatory submission documents and responses to Regulatory questions e.g., INDs, NDAs
• Represent the company’s clinical supplies function, presenting at Global Investigator Meetings
• Develop supply strategies to be adopted at the program level; oversee budgets at a program and study level, ensuring challenge, review, presentation, and approval of initial budget and adherence to the supplies budget through the lifecycle of the program
• Direct and oversee pack/label and distribution of clinical supplies for the duration of the clinical study through study completion and closeout, including resupply as needed
• Manage inventories at depots and sites and ensure on-time delivery with minimal overage of clinical supplies. Coordinate purchasing activities with other departments to maintain inventory at planned levels
• Have an in-depth understanding of blinding, possible issues and maintaining the blind throughout the conduct of the studies
• Identify supply risks and implement corrective actions and mitigation strategies to maintain supply continuity
• Ensure compliance with company internal procedures and GXP requirements by close collaboration with QA and Clinical Operations and approved vendors
• Be a subject matter expert for the IRT (Interactive Response Technology) drug supply and reconciliation modules. Be a key member of the sponsor team with a strong understanding of patient randomization and strata and establishing IRT design and User Acceptance Testing supporting clinical teams
• Other duties as assigned

Benefits

• Competitive benefits package
• Generous PTO