Sr. Manager, Clinical Supply Chain Ops

BioMarin Pharmaceutical Inc.San Rafael, CA

About The Position

We are seeking an experienced and driven Senior Manager of Clinical Supply Chain Operations to collaborate on the end-to-end clinical supply chain execution across our global study portfolio. This individual will play a critical role in program management, forecasting, scenario planning, and risk mitigation to ensure timely and uninterrupted availability of clinical trial materials (CTM). The ideal candidate is both strategic and hands-on, with strong cross-functional collaboration skills and a deep understanding of the clinical development lifecycle. This is an exciting opportunity to contribute to a growing organization by applying best-in-class planning principles, digital technologies, and operational excellence.

Requirements

  • Bachelor’s degree in a science-related field; advanced degree preferred
  • 8+ years of experience in clinical supply chain, planning, or operations within the biotech/pharma industry
  • Proven ability to lead cross-functional teams, influence stakeholders, and manage complex supply planning scenarios.
  • Experience with digital planning tools (e.g., SAP, Tableau).
  • Experience using the Smart Supplies Forecasting tool is preferred.
  • Strong understanding of GxP, ICH, and regulatory requirements governing clinical supply activities
  • Strong understanding of technical drug development is advantageous

Nice To Haves

  • Rare disease therapeutics clinical development

Responsibilities

  • End-to-end global clinical supply operations management, including but not limited to timelines to ensure alignment overall clinical development, manufacturing, pack and label, logistics, inventory, reconciliation, and IRT, maintaining Clinical Supply Plan up to date.
  • Translate clinical protocols into integrated demand forecasts and risk-adjusted supply plans across regions.
  • Support long-range planning, scenario modeling, and financial forecasting to ensure uninterrupted supply and potentially identify cost efficiency.
  • Provide input to Interactive Response Technology (IRT) system design, testing. Maintain system to support supply tracking and randomization.
  • Monitor and track manufacturing timelines and ensure alignment with clinical supply needs.
  • Responsible for inventory management at patient level to ensure zero out of stock situations.
  • Partner with key stakeholders to understand details of clinical study design, planning and execution, such as examples below (but not limited to) : o GEO (Global External Operations) to monitor and understanding status of manufacturing operations (DS, DP and FG), storage and distribution o GSO (Global Study Operations) to understand study milestones, upcoming visits, site inventory, and ensure supply continuity o CSC Planning to provide demand and understand supply forecasting
  • Lead Clinical Supply Chain (CSC) operations at the study and program level, including budget and timeline development and adherence.
  • Serve as the primary CSC representative in cross-functional governance forums.
  • Collaborate with internal and external stakeholders to align supply strategy with development, regulatory, and operational needs.
  • Influence program-level decisions to optimize timelines, patient access, and budget compliance.
  • Ensure compliance with global GxP, ICH, and regional regulatory requirements in clinical supply operations.
  • Support regulatory filings and inspections as a subject matter expert; lead TMF preparation for investigational product supply.
  • Drive SOP development, process improvements, and audit readiness to enhance operational scalability.
  • Lead digital transformation initiatives including forecasting tools, dashboards, and AI-driven analytics to improve resilience and sustainability.
  • Other duties as assigned
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