Global Clinical Supplies Lead — Strategy & Execution

PTC Therapeutics; Warren Township (NJ); Presencial; USD 166.000 - 195.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Incentive bonuses

Medical, dental, vision insurance

Descripción de la vacante

BioNJ Inc. seeks an Associate Director, Clinical Supplies to oversee forecasting, planning, packaging, labeling, distribution, reconciliation and destruction of Clinical Trial Materials for global trials.

The role collaborates with CMOs, CROs, vendors, and clinical sites to ensure CTM availability while adhering to cGMP, GCP, and ICH guidelines. Travel is expected 10–20% and leadership of a growing clinical supplies team is anticipated.

Formación

• Bachelor’s degree with 8+ years of relevant clinical drug supplies experience or Master’s with 6+ years.
• Hands-on GMP, GCP, and ICH knowledge as related to CTM labeling, packaging and distribution operations.
• IRT (IVRS/IWRS) experience; proficiency with MS Project and Microsoft Office.

Responsabilidades

• Oversee forecasting, planning, packaging, labeling, distribution, reconciliation, and destruction of CTM for global trials.
• Manage CTM distribution with CMOs and external providers and coordinate with CROs and shipping agents.
• Ensure regulatory compliance (cGMP, GCP, ICH) and ALCOA+ documentation; provide monthly status updates.

Conocimientos

GMP/GCP/ICH knowledge

IRT experience

MS Project

Verbal and written communication

Planning and time management

Clinical supply shipping

Educación

Bachelor’s degree with 8+ years of experience

Master’s degree with 6+ years of experience

Herramientas

Microsoft Office (MS Project)

Descripción del empleo

BioNJ Inc. seeks an Associate Director, Clinical Supplies to oversee forecasting, planning, packaging, labeling, distribution, reconciliation and destruction of Clinical Trial Materials for global trials.

The role collaborates with CMOs, CROs, vendors, and clinical sites to ensure CTM availability while adhering to cGMP, GCP, and ICH guidelines. Travel is expected 10–20% and leadership of a growing clinical supplies team is anticipated.