Associate Director, Clinical Supply Management

About the role

Novartis is looking for an Associate Director, Clinical Supply Management to lead, represent, manage and support its US Medical Affairs CSM team. You will develop the drug supply strategy and tactical approach for Sponsored, Investigator Initiated (IITs), Managed Access and Research Collaboration trials, overseeing projects end to end and keeping accountability for deliverables. The role is based at the East Hanover or Fort Worth site, cannot be done remotely, requires up to 15% travel and considers only local candidates.

Key responsibilities

• Oversee the end-to-end supply strategy from forecast to clinical sites, review planning assumptions and help choose the supply model (packaging/distribution)
• Ensure regulatory alignment so that FPFV readiness is covered, and manage IMP supply and bulk product inventory with quality and compliance
• Turn early supply and financial forecasts into demand forecasts and advise on packaging design options in protocol design and clinical meetings
• Work with cross-functional partners to execute supply plans, solve problems and ensure patient supply without compromising quality, cost or delivery
• Lead cost assessments of labeling, packaging, distribution and comparators, and collaborate with Finance and Contracts on spend and third-party contracts
• Lead the setup of IRT and simulation tool systems, and use AI-enabled insights to improve forecasting, inventory, warehousing and depot-to-site distribution
• Onboard new vendors with QA Vendor Management and GMP Audit, support GxP audits, and lead externalization activities with CROs, vendors, distributors and depots
• Set working practices and SOPs, identify process improvements and ensure cross-program consistency

Required profile

• Bachelor's degree and 10+ years of directly related experience, or an equivalent combination of education and experience
• Knowledge of cGMP, 21 CFR Part 11 and Annex 13
• Knowledge of the drug development process
• Experience collaborating with cross-functional teams

Preferred requirements

• Knowledge of setting up and managing Interactive Response Technology and simulation tools

What we offer

• Expected salary of $136,600 to $257,400 per year, with a performance-based cash incentive and possible annual equity awards
• Health, life and disability benefits, 401(k) with company contribution and match
• Vacation, personal days, holidays and other leaves