Senior Director, Clinical Supply & Supply Chain

The Senior Director, Clinical Supply & Supply Chain is responsible for enterprise-wide strategy, planning, execution, compliance, and governance of drug substance and drug product supply across clinical and pre-commercial programs. This leader ensures uninterrupted clinical supply, regulatory compliance, commercial readiness, and scalable supply chain infrastructure aligned with corporate growth objectives. This role owns global integrated business planning (IBP), supply risk management, CDMO governance, external manufacturing strategy, packaging and labeling oversight, depot strategy, distribution compliance, and launch readiness. The Senior Director partners closely with Technical Operations, CMC, Quality, Regulatory, Clinical Operations, and Finance to align supply strategy with portfolio priorities, regulatory requirements, and long-range financial plans. This position reports to the SVP/Head of Technical Operations and will be instrumental in building scalable infrastructure as LB transitions from clinical stage to commercial organization.

Key Responsibilities

Enterprise Supply Strategy

• Develop and execute global supply chain strategy across clinical and pre-commercial programs.
• Lead long-range capacity planning across API and drug product manufacturing, including launch scenario modeling.
• Establish inventory policies, safety stock strategies, and lifecycle management plans.
• Own integrated business planning (IBP) process across functions.
• Develop formal supply risk management framework, including dual sourcing strategies and contingency planning.

Clinical Supply Governance

• Oversee global demand forecasting across double-blind (DB) and open-label extension (OLE) programs.
• Align packaging configurations and labeling strategies with protocol design and regulatory requirements.
• Oversee IRT/RTSM integration and supply alignment.
• Lead proactive top-up campaign planning to prevent stockouts.
• Lead cross-functional supply war room governance during high-risk periods.
• Communicate supply risks transparently to executive leadership.

CMC & Technical Operations Interface

• Partner with CMC on tech transfer strategy from clinical to commercial scale.
• Lead clinical-to-commercial tech transfer execution and validation readiness.
• Ensure PPQ readiness and launch scale-up execution.
• Align supply plans with stability programs, shelf-life strategy, and expiry management.
• Support NDA Module 3 supply documentation and filing readiness.

External Manufacturing & Vendor Strategy

• Own CDMO and 3PL governance framework.
• Negotiate supply and quality agreements and capacity reservations.
• Monitor vendor KPIs (cost, schedule, compliance, quality).
• Develop dual sourcing strategies to mitigate supply risk.

Data, Systems & Infrastructure Modernization

• Implement and optimize ERP/MRP and supply planning systems (e.g., SAP, NetSuite, Oracle, Kinaxis).
• Establish scalable supply visibility dashboards and data governance standards.
• Drive data analytics-driven supply optimization and forecast accuracy improvements.
• Ensure integration across clinical systems (IRT, EDC) and supply planning platforms.
• Architect scalable infrastructure to support transition from clinical to commercial operations.

Commercial Readiness & Launch Planning

• Prepare end-to-end supply chain infrastructure for launch.
• Lead launch quantity planning and demand scenario modeling.
• Align packaging, labeling, and distribution with regulatory and commercial strategy.
• Support COGS forecasting and gross-to-net modeling in partnership with Finance.
• Develop channel, wholesaler, and distribution readiness strategy.
• Establish returns and chargeback readiness processes.

Qualifications

• 12 + years of progressive experience in biopharma supply chain leadership.
• Experience scaling supply organizations from clinical-stage through commercial launch.
• Deep experience managing global CDMOs, depots, and 3PLs.
• Regulatory inspection support experience (FDA, EMA, MHRA preferred).
• Experience leading clinical-to-commercial tech transfer and PPQ readiness.
• Strong financial acumen, including COGS forecasting and launch modeling.
• Experience implementing ERP/MRP or advanced supply planning systems.
• Demonstrated success building supply risk management frameworks.
• Small molecule oral solid dose experience preferred; CNS experience a plus.

Performance Metrics (What Success Looks Like)

• Zero clinical stockouts.
• On-time manufacturing campaigns.
• Forecast variance less than 10%.
• Budget adherence and accurate COGS forecasting.
• Strong audit and inspection outcomes.
• Scalable systems implemented to support launch readiness.

The posted salary range reflects the minimum to maximum base pay for this position in the specified location. Actual compensation may vary based on factors such as geographic location, experience, education, licensure requirements, and skill level, and will be determined at the time of offer. Base Salary Range: $260K – $280K The Values We Hope You Share

• Purpose Driven– We are optimistic, focused and committed to delivering on our vision. We are hard-working, compliant, relentless and impatient in our pursuit of treatments. We set competitive company goals to significantly and positively impact the lives of our patients, employees and shareholders. We have a sense of urgency to every action we make.
• Transparent – We trust each other and expect honest and open communication to enable good decision making. We are humble, genuine and direct. Words match our behaviors. We hold each other accountable. We embrace the tough conversations to achieve success.
• Bold – We are courageous in our pursuit of excellence. Unafraid of risks. Unafraid of challenging assumptions. Unafraid of challenges. Unafraid of success.
• Intelligent – We are curious, passionate and self-aware. We are agile, adaptable and seek diverse experience, knowledge, and skills to make informed, data driven decisions. We anticipate the needs of others, and we adapt quickly to challenges and find solutions. We rely on our collective experiences to diligently develop, strategically plan and efficiently execute our vision.
• Unified – We collaborate as we strive for excellence. We rely on each other, and we have each other’s backs. We encourage constructive feedback to continually improve. We support each other; we laugh together. We celebrate each other’s successes and band together in times of hardship. We foster and appreciate genuine relationships.

Our values underpin the employee experience at LB Pharmaceuticals. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively. Apply tot his job Apply To this Job