Associate Director, Clinical Supply Management

About the Role

As the Associate Director, Clinical Supply Management, you will lead, represent, manage, and support the US Medical Affairs CSM team by developing drug supply strategy and tactical approach for Sponsored, Investigator Initiated (IITs), Managed Access, and Research Collaboration trials. This position will be located at the East Hanover or Fort Worth site and will require up to 15% travel (domestic and/or international). Relocation is not provided, and only local candidates will be considered.

Key Responsibilities

• Oversees the entire end-to-end supply strategy (from high-level forecast to clinical sites) and reviews planning assumptions in supply plans and forecasts.
• Participates in decision-making to select the most appropriate supply model (packaging/distribution) and ensures alignment with regulations for FPFV readiness.
• Manages Investigational Medicinal Product (IMP) supply for clinical trials and bulk product inventory, maintaining quality and compliance.
• Advocates for early supply and financial forecasting to support long-term supply and capacity planning.
• Provides clinical supply insights in protocol design and meetings, presenting packaging options and influencing recommendations.
• Works with cross-functional teams to execute supply chain plans, identify obstacles, and resolve issues to ensure patient supply without compromising quality, cost, or delivery.
• Assesses risks and defines strategies to ensure supply continuity and flexibility.
• Leads cost assessment for labeling, packaging, distribution, and comparator activities, collaborating with Financial and Contracts teams for cost controls.
• Sets up Interactive Response Technology (IRT) & Simulation Tool systems, incorporating supply strategies for studies.
• Leverages AI-enabled insights and automation to optimize clinical supply planning, execution, and distribution while championing responsible AI adoption.
• Acts as a CSM Subject Matter Expert (SME) in onboarding new vendors and supports GxP audits.
• Manages relationships with CROs, vendors, IRT providers, suppliers, distributors, and depots, establishing strong partnerships.
• Develops working practices and SOPs to support industry best practices and identifies process improvement opportunities.

Essential Requirements

• Bachelor’s degree with 10+ years of directly related experience OR equivalent combination of education and work experience.
• Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements.
• Understanding of the drug development process.
• Experience collaborating with cross-functional teams.

Preferred Requirements

• Knowledge of Interactive Response Technology and Simulation Tools set-up and management.

Pay

The salary for this position is expected to range between $136,600 and $257,400 per year. The final salary is determined based on factors like relevant skills, experience, and periodic reviews. Compensation includes a performance-based cash incentive and potential annual equity awards.

Benefits

US-based eligible employees receive a comprehensive benefits package, including health, life, and disability insurance, a 401(k) with company contribution and match, and a generous time off package (vacation, personal days, holidays, and other leaves).