Lisa Hribko

About Lisa Hribko

Experienced results-oriented Clinical Supply Director with a demonstrated history of working in the pharmaceutical industry. Strong professional skilled in Clinical Supply Forecasting and Operations, System Development and Implementation, Team Building, and Management.

Experience

1. Director, Clinical Supply Management

   Biohaven

   Apr 2022 — Present · New Haven, CT, US

   Directs and manages clinical supply planning, forecasting, labeling/packaging, distribution and risk management for assigned Biohaven Pharmaceuticals clinical products/clinical trials. • Collaborates cross-functionality with internal and external partners to determine clinical supply needs and support regulatory submissions throughout the life of the study. • Supports financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline.• Develops the secondary packaging and labeling strategy to support individual clinical trials (global and domestic, all phases) in accordance with study and program timelines. Recommend changes to labeling/packaging schedules for clinical drug products based on study progress and or any changes with the study plans• Oversees and actively manages relationships with contract clinical labeling/packaging/distribution vendors to ensure production and inventory targets are communicated and met. • Manages the clinical packaging vendors to develop the optimal packaging and resupply schemas, develop supply strategies, manage depot/site distribution/stocking requirements, and manage expiration/retest date requirements. Develops and communicates accurate lead time requirements to clinical packaging/distribution vendors as well as internal Supply Chain.• Supports design and set-up of IRT system by providing input to User Requirement Specifications. Participates in UAT system testing to ensure the system is functioning appropriately, prior system go live.• Leads process initiatives and SOP creation as required.

Education

• Quinnipiac University

  AS, Business Administration

  1990 — 1993

• Quinnipiac University

  BS, Business Studies

  1993 — 1998

Skills

• Good Clinical Practice (Gcp)
• Oncology
• Supply Management
• Software Documentation
• Clinical Trials
• Management
• Team Building
• Pharmaceutical Industry
• Business Process Improvement
• Sop
• Fda
• Biotechnology
• Forecasting
• Continuous Improvement
• Research and Development (R&D)
• Standard Operating Procedure (Sop)
• Budgeting
• Procurement
• Supply Chain Management
• Business Development
• Sap
• Process Improvement
• Pharmaceutical Sales
• Team Leadership
• Contract Negotiation
• Sales Operations
• Customer Service
• Project Planning
• Supply Chain
• Training
• Communication
• Leadership
• Clinical Research
• Cross-Functional Team Leadership
• Gmp