BridgeBio

Supply Chain

• Manage a global team of supply chain professionals responsible for clinical and commercial end-to-end supply chain
• Manage all aspects of commercial supply chain, including Drug Substance and Drug Product CMOs, Packaging and Labeling with CPOs, and Finished Good receiving, storage and distribution at 3PLs
• Coordinate logistics of material transfer for clinical and commercial drug substance, drug product and components to/from international CMOs/CPOs, managing exportation, applicable USDA/FDA licenses and permits, VAT recovery and customs brokers
• Own the global Sales & Operations Planning (S&OP) process for all commercial products, coordinating demand planning, finance and communicating final supply plans to global partners
• Own and actively manage the commercial supply plan, commercial inventory (in process and finished goods), shelf life and expiration management
• Own and manage all serialization activities for commercial products globally
• Manage clinical packaging and labeling activities including label design, translation, production, distribution and inventory management
• Provide clinical demand signals and translate total demand into a forecast based on clinical protocols or study overviews
• Prepare clinical supply plans including determination of supply overage amounts; monitor inventory and provide regular inventory updates to project teams
• Monitor clinical drug expiry/retest dating; initiate inventory release and re-supply; serve as the unblinded inventory manager
• Manage domestic and international distribution and logistics for clinical programs, including importing/exporting clinical supplies and developing distribution instructions with clinical supply vendors
• Support budget activities, including managing supplier contracts, PO generation and invoicing approvals for clinical and commercial purchases
• Work collaboratively with QA to manage batch release, final release, temperature excursions and support investigations of deviations
• Liaise with CMC and clinical operations and evaluate new CMOs/CPOs for commercial supply chain
• Work with Global Trade & Distribution and global Finance teams to manage global 3PLs, ensuring finished good inventory management, distribution, logistics, sales and revenue reporting
• Generate and maintain global SOPs in Veeva QMS and ensure compliance with industry standards
• Develop and maintain strong cross-functional collaboration with CMC, Clinical Operations, Market Access, Finance, Quality, and Regulatory Affairs

VP, Supply Chain

Project Manager

• Develop, implement, and manage regulatory strategies to support global submissions, product approvals, and lifecycle management, ensuring alignment with company objectives and regulatory requirements
• Monitor and interpret global regulatory guidelines and policies to ensure company compliance
• Oversee the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, MAAs, and other regional filings
• Manage timeline preparation for CMC, Clinical, and Nonclinical Modules, ensuring successful and timely global marketing application submissions
• Track submission deliverables, manage workflows, and provide support for regulatory submissions by coordinating with team members
• Collaborate with cross-functional teams to align regulatory activities with overall project goals, providing hands-on contributions when necessary
• Lead program activities, including creating and managing reports, dashboards, and scorecards, and conduct risk assessments to keep projects on track
• Communicate program status and escalate risks to stakeholders, ensuring smooth coordination of activities and resolution of issues with cross-functional partners
• Provide Overall PM support, including leading or co-leading meeting series with cross-functional teams, developing and managing timelines, tracking action items, and preparing for meetings and interactions with international regulatory agencies
• Ensure effective communication and collaboration between internal teams and external consultants, aligning regulatory strategies and submission requirements with project milestones
• Provide regulatory support for internal and external audits, ensuring readiness and compliance

VP, Supply Chain

Associate Director/Director, Regulatory Project Management