Head of Supply Chain Operations

Head Of Supply Chain Operations

Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.

Position Summary

Zentalis Pharmaceuticals is seeking an Executive/Senior Director, Supply Chain to join our Technical Operations team. Reporting to the Chief Technical Officer, this role leads a team responsible for establishing, implementing, and managing supply chain strategy and activities within the organization and across a network of external vendors used for the clinical supply of Zentalis' investigational products and future commercial supply. This role will drive the activities leading to the implementation of inventory management and distribution systems consistent with meeting GMP, GDP, GCP, clinical development programs and corporate objectives. They will be responsible for the management of vendors including performance metrics, contractual agreements, and supplies. They will provide leadership to activities that will support several clinical programs and protocols; label creation, labelling activities, shipment and logistics operations by interacting with internal and external customers and suppliers to accomplish program objectives.

Essential Duties And Responsibilities

• Lead the overall Supply Chain Team, with a focus on optimization, flexibility, risk analysis and planning
• Serve as a mentor and coach for career development of the supply chain team
• Acts as the main liaison within Clinical Operations, Manufacturing, Quality, and external partners to support key tasks related to forecasting, planning, shipping, logistics, labeling, packaging and distribution of clinical materials and future commercial distribution
• Manage country logistics for shipping and importation and monitoring of enrolment, drop-out rates and actual supply needs.
• Re-assess program needs to ensure forecasts are current and the impact on key raw materials, API and Drug Product
• Develop and formalize robust processes/procedures related to clinical & commercial supply chain activities in compliance with global regulations
• Develop an inventory strategy per program, study and region
• Manage processes for label creation and approvals, including translations for all countries and monitor drug expiry, and the appropriate inventory re-supply
• Responsible for the sourcing of comparators and matching placebo as needed
• Responsible for developing and managing annual supply chain budget
• Develop and support a vendor management process in cooperation with legal including vendor selection for each program/study, RFP, and SOWs with vendors
• Optimize the governance process with external vendors including inventory reports, budget and spending reviews
• Support of regulatory filings including IND and NDA submission information
• Monitor conformance to clinical supplies inventory management with Interactive Response Technology (IRT) standards when implemented

Knowledge/Skills/Abilities Required

• Complete and advanced understanding cGMP and cGCP requirements for clinical and commercial supply chains
• Strong leadership skills; demonstrated ability to build/lead a team and influence at all levels of the organization
• Ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion
• Strong analytical, problem solving and critical thinking skills
• Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership
• A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, who communicates effectively with executive leaders and key external partners
• Experience in managing third-party clinical supply operations
• Experience in building and managing inventory management systems
• Experience in building and managing strong teams
• Comprehensive knowledge of IRT design for control of drug distribution and inventory management
• Knowledge of import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance
• Strong understanding of IMP, QP, cGMP and cGCP practices and requirements
• Bachelor's degree in scientific/pharmacy field
• A minimum 15+ years of leadership experience in Clinical Supply and Supply Chain operations required
• Available to travel if/when needed