Onsite Associate Director, Global Clinical Supply

Summit Therapeutics; Princeton, Palo Alto (NJ, CA); Vor Ort; USD 174.000 - 204.000; Vollzeit

Zusammenfassung

Summit Therapeutics Inc. seeks an Associate Director, Clinical Supply Management to lead global supply chain activities for multiple NSCLC studies.

Based in Princeton, NJ or Palo Alto, CA onsite, you will oversee demand and supply planning, inventory, packaging and labeling, distribution, and regulatory compliance, partnering with CDMOs and IXRS providers. You will manage and develop a CSM team, drive budgets and schedules, and push continuous improvement and risk management across locations to

Qualifikationen

• BSc, MSc, engineering or pharmacy degree, or equivalent, with a minimum of 8+ years of progressive supply chain experience in pharma/biotech/CDMO
• Proven success leading complex international clinical studies and product supply chains with regulatory/GMP knowledge
• Experience in people-management and developing talent
• Ability to translate strategy into executable priorities, with KPIs and metrics
• Strong process standardization, continuous-improvement and root-cause analysis skills
• Experience with IXRS design, setup and UAT; skilled in forecasting and supply planning tools
• Budgeting, risk management and ability to manage multiple priorities
• Outsourcing, supplier governance and performance management expertise
• Knowledge of drug development and FDA/EMA/PMDA expectations including GMP, GCP, Annex 13

Aufgaben

• Supports the Senior Director in developing functional strategy, operating plans, budgets, governance and objectives
• Leads day-to-day execution for studies and products, ensuring forecasting, supply planning, inventory and compliance
• Represents Senior Director in cross-functional forums and supplier reviews; escalates issues with recommendations
• Develops direct reports; translates priorities into individual objectives and career development
• Coordinates team activities; removes barriers and escalates material risks to Senior Director
• Oversees packaging, labeling, supply and resupply strategies across global locations
• Develops budgets, resource plans and integrated schedules; monitors variances and resolves them
• Manages CDMO/service-provider activities from RFP to operations with KPIs
• Supports IXRS selection, design, UAT and ongoing performance as required
• Drives standard work, dashboards and KPIs; uses data trends for improvement
• Leads continuous-improvement initiatives to strengthen inspection readiness and processes
• Supports regulatory submissions, audits and SOP/CAPA management

Kenntnisse

Supply chain leadership

Global cross-functional coordination

GxP compliance

Forecasting & planning

Budget & cost management

supplier governance

Ausbildung

BSc/MSc in science or engineering or pharmacy

Tools

IXRS

CDMO management

Jobbeschreibung

Summit Therapeutics Inc. seeks an Associate Director, Clinical Supply Management to lead global supply chain activities for multiple NSCLC studies.

Based in Princeton, NJ or Palo Alto, CA onsite, you will oversee demand and supply planning, inventory, packaging and labeling, distribution, and regulatory compliance, partnering with CDMOs and IXRS providers. You will manage and develop a CSM team, drive budgets and schedules, and push continuous improvement and risk management across locations to