Vice President, Supply Chain

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of Enliven’s global supply chain strategy while preparing the organization for late-stage development, regulatory approval, and commercial supply.

• Ensure continuous supply of investigational products across Enliven’s clinical programs.

• Collaborate with CMC, Clinical Operations, Quality, Regulatory, Commercial, Finance, Legal, and other departments.

• Convert clinical protocols, enrollment forecasts, development plans, and manufacturing timelines into demand forecasts, supply plans, inventory strategies, and budgets.

• Supervise forecasting, production planning, packaging, labeling, distribution, inventory management, logistics, returns, reconciliation, and destruction.

• Manage global logistics, import/export operations, customs documentation, depot strategies, and country-specific labeling and distribution requirements.

• Establish inventory and safety stock strategies.

• Identify supply gaps, capacity limitations, and logistics challenges; create contingency and mitigation plans.

• Lead the resolution of supply disruptions and unforeseen events that impact clinical timelines or patient supply.

• Oversee IRT-related supply strategies and comparator sourcing.

• Assist with clinical and regulatory documentation, submissions, inspections, and audit readiness activities.

• Develop and implement the transition roadmap from clinical-stage supply to scalable commercial supply.

• Create processes, systems, governance, and external partnerships for late-stage development, launch, and commercial supply.

• Direct commercial supply and launch-readiness planning, including demand and supply planning, serialization, distribution, logistics, 3PL strategy, and product traceability.

• Collaborate with Commercial and Finance on integrated forecasting, demand planning, and S&OP/IBP capabilities.

• Formulate launch scenarios and contingency plans.

• Oversee CMOs/CDMOs, packaging and labeling providers, depots, logistics providers, and 3PLs.

• Lead vendor evaluation, selection, contracting, onboarding, governance, and performance management, including RFPs and SOWs.

• Develop sourcing, contracting, capacity-planning, and business-continuity strategies.

• Maintain visibility into inventory, supply status, risks, budgets, and key decisions; provide updates to senior leadership.

• Create scalable SOPs, planning processes, systems, and performance metrics.

• Serve as a supply chain subject-matter expert during audits and inspections.

• Represent Supply Chain or CMC/Technical Operations in program teams, governance forums, and leadership discussions.

• Communicate supply strategy, readiness, risks, trade-offs, and investment needs to executive leadership.

• Provide guidance and support to supply chain team members.

⛳️ Requirements

• A Bachelor’s degree in supply chain, engineering, life sciences, business, or a related field is required; an advanced degree is preferred.

• Approximately 15 or more years of increasingly responsible experience in pharmaceutical or biotechnology supply chain roles.

• Extensive, hands-on experience in leading global clinical supply, including forecasting, inventory management, packaging and labeling, distribution, logistics, and oversight of external partners.

• Proven experience in managing supply chains for pivotal/Phase 3 clinical development and transitioning products from clinical-stage operations to commercial readiness.

• Direct experience in establishing commercial supply chain capabilities and serving in a supply chain leadership role during at least one pharmaceutical product launch, including support for NDA readiness and pre-approval inspections.

• Strong understanding of clinical and commercial supply requirements, including demand planning, inventory strategy, packaging and labeling, serialization, distribution, 3PL management, and product traceability.

• Experience managing CMOs/CDMOs and other outsourced supply partners within a virtual or highly outsourced biotechnology organization.

• Background in building and leading supply chain teams, including planning for internal staffing, consultant support, and outsourced capabilities.

• Strong knowledge of GMP, GDP, and applicable global clinical supply requirements.

• Experience leading or significantly participating in the implementation of ERP/planning/inventory management/supply visibility systems.

• Demonstrated ability to foresee supply gaps, develop practical contingency plans, and quickly resolve disruptions.

• Capacity to work effectively at both strategic and tactical levels in a small or mid-sized biotechnology company.

• Excellent cross-functional leadership, communication, financial judgment, negotiation, and problem-solving skills.

• Ability to manage multiple priorities and make sound decisions in a fast-paced, evolving environment.

• Preferred experience in building clinical and commercial supply capabilities for an emerging biotechnology company’s inaugural commercial product.

• Familiarity with small-molecule pharmaceutical products and outsourced global manufacturing and distribution networks.

• Experience supporting global, multi-region clinical trials.

• Experience assisting U.S. and international product launches.

• Working knowledge of IRT systems.

• A background check is required as a condition of employment.

🏝️ Benefits

• A bonus may be provided.

• Equity may be offered.

• Occasional evening, weekend, holiday, and on-call work may be necessary based on job duties.

• Approximately 15% travel may be expected.

• We are an equal opportunity employer.