Vice President or Senior Vice President, Clinical and Commercial Supply Chain

Role Summary

Vice President or Senior Vice President, Clinical and Commercial Drug Supply, to lead and execute the company’s operations and strategies to ensure clinical and commercial drug supply. This role focuses on large-scale external commercial manufacturing, supply chain functions, product quality, regulatory compliance, and on-time global supply, with initial emphasis on U.S. commercial manufacturing launch readiness for the lead program Darovasertib in Uveal Melanoma and ongoing global launch plans and product life-cycle management.

Responsibilities

• Develop and own the global supply strategy for clinical and commercial phases ‚Äî including demand forecasting, capacity planning, buffer stocks, and supply continuity.
• Define and implement a Sales & Operations Planning (S&OP) process aligned with commercial, finance, regulatory, and manufacturing functions.
• Assess and manage supply risk (e.g., supplier capacity constraints, regulatory delays, geo-risks) and build risk mitigation plans (dual sourcing, safety stocks, alternate routes).
• Oversee supply of investigational products (IPs) for clinical trials, including packaging, labeling, distribution, and returns.
• Lead tech transfers (from clinical to commercial) and scale-up from pilot to commercial processes, ensuring continuity.
• Work with external CDMOs and logistics/3PL partners to ensure timely supply for trials and launches.
• Manage commercial-scale manufacturing supply chains, packaging, serialization, warehousing, and distribution, including management of direct reports.
• Ensure readiness for product launch: validation, qualification, capacity ramp, regulatory compliance (serialization, track & trace, import/export).
• Oversee inventory management, allocation, demand-supply balancing, replenishment, and trade compliance.
• Select, contract, qualify, and manage performance of CDMOs, CMOs, packaging, testing, and logistics vendors.
• Oversee adherence to SLAs, quality metrics, audits, and change control management.
• Collaborate with cross-functional teams to align supply with product strategy (CMC, Regulatory, Quality, Manufacturing, Commercial, Finance, Legal, Project Management).
• Serve as a member of the program or portfolio leadership team; provide executive updates and risk escalations.
• Lead the supply organization: hiring, mentoring, performance management, and capability building.
• Drive process improvement, system upgrades (e.g., ERP, supply chain digitalization), metrics/KPIs, and continuous optimization.
• Ensure operations comply with GMP, GDP, global import/export regulation, serialization & traceability, and regulatory requirements.
• Lead or support regulatory submissions related to manufacturing, supply, serialization, and drug product changes (e.g., in CMC sections).
• Prepare for and manage regulatory audits or inspections relevant to drug supply and logistics.
• Provide regular updates to the CEO, executive leadership team, and the board on the overall strategy and deliverables related to the clinical and commercial supply chain.

Qualifications

• Advanced Degree (Ph.D. preferred) in life sciences, chemistry, pharmaceutical sciences, engineering, pharmacy, chemical engineering, or related field
• Minimum 20+ years‚Äô experience in the biotechnology and pharmaceutical industry, with extensive experience in pharmaceutical/biotech operations, including clinical and commercial supply; proven track record transitioning products from clinical to commercial stage
• Demonstrated experience in supply chain management, CDMO/CMO oversight, technology transfers, vendor management, logistics, and serialization
• Technical expertise and strategic understanding of GMP regulations, quality systems, and global supply chain management; knowledge of CFR Parts 58, 210, and 211; ICH; and FDA regulatory guidance
• Commercial-stage subject matter expertise with leadership presence in commercial-stage technical operations and continuous improvement initiatives
• Regulatory acumen and experience with global regulatory filings, inspections, and compliance standards, including authoring/reviewing Module 3 documentation
• Strong leadership and ability to build and lead cross-functional teams, manage complex projects, and influence across a matrixed organization

Skills

• Strategic planning and demand forecasting
• Supply chain risk management and continuity planning
• CDMO/CMO oversight and vendor management
• Technology transfers and scale-up for clinical to commercial
• Regulatory compliance for GMP/GDP and serialization
• S&OP development and cross-functional collaboration
• Leadership, coaching, and organizational development
• ERP and supply chain digitalization initiatives

Education

• Advanced degree as specified in Qualifications (Ph.D. preferred)

Additional Requirements

• Onsite work in South San Francisco, CA required with regular in-office presence