Lead, Clinical Supplies & Trial Logistics

PTC Therapeutics, Inc.; New Jersey; On-site; USD 166,000 - 195,000; Full time

Benefits offered by this job

Incentives

Benefits package

Job summary

PTC Therapeutics, Inc. is seeking an Associate Director, Clinical Supplies to oversee forecasting, packaging, labeling, distribution, and destruction of CTM for global trials.

You will lead a cross-functional team and collaborate with CMOs, CROs, and study sites to ensure continuous clinical supply in compliance with cGMP, GCP, and ICH guidelines. The role emphasizes program-level planning, budget management, and ensuring audit-ready documentation, with a focus on regulatory compliance and

Qualifications

• Hands-on GMP, GCP and ICH knowledge applied to CTM labeling, packaging and distribution.
• Experience supporting CTM labeling, packaging and distribution operations.
• Proficiency with IVRS/IWRS systems and clinical supply processes.

Responsibilities

• Lead CTM forecasting, packaging planning, and distribution across trials.
• Coordinate with CMOs/CROs and internal teams to ensure supply readiness.
• Develop budgets, track costs, and review monthly vendor invoices.
• Maintain ALCOA+ regulatory documentation and audit readiness.
• Provide risk mitigation and monthly status reports on trials.

Skills

GMP/GCP/ICH knowledge

IVR/IWRS experience

Verbal & written communication

Project coordination

Cross-functional collaboration

Analytical thinking

Microsoft Project proficiency

Education

Bachelor's degree

Master's degree (preferred)

Tools

MS Project

Job description

PTC Therapeutics, Inc. is seeking an Associate Director, Clinical Supplies to oversee forecasting, packaging, labeling, distribution, and destruction of CTM for global trials.

You will lead a cross-functional team and collaborate with CMOs, CROs, and study sites to ensure continuous clinical supply in compliance with cGMP, GCP, and ICH guidelines. The role emphasizes program-level planning, budget management, and ensuring audit-ready documentation, with a focus on regulatory compliance and