Director of Clinical Supply Chain Management - 100% Remote
We are seeking an experienced and motivated professional to join our client's team as a Director of Clinical Supply Chain Management. The successful candidate will lead the setup and management of clinical supply chains for our innovative clinical programs across multiple phases. This role will oversee all aspects of supply chain operations for clinical trials, including managing vendors, overseeing drug distribution, packaging, labeling, and ensuring timely availability of investigational medicinal products (IMP) at clinical sites.
Key Responsibilities:
- Oversee clinical supply activities including label generation, packaging, labeling, distribution, inventory management, and cold chain management.
- Ensure prompt supply availability for the timely startup of new clinical studies.
- Manage drug product inventory and distribution in collaboration with Contract Manufacturing Organizations (CMOs), ensuring compliance with country requirements and logistical timelines.
- Oversee Clinical Supply CMOs and manage global strategies in Interactive Response Technology (IRT) systems.
- Develop and maintain Clinical Supply SOPs and manage departmental deviations.
- Collaborate with cross-functional teams (Clinical Operations, QA, CMC, and Regulatory) to execute clinical supply strategies and proactively address potential risks.
- Serve as the internal point of contact for product issues, temperature excursions, and deviations from clinical sites or depots, collaborating with Quality Assurance as necessary.
Qualifications:
- B.S. in a scientific, healthcare, or related field with 10+ years of global clinical supply chain experience in the biotechnology sector. APICS certification is a plus.
- Proven experience establishing, managing, and refining clinical supply chains in the biotechnology industry.
- Strong understanding of GxP requirements (GMP, GCP, GDP).
- Excellent attention to detail, follow-up, and problem-solving skills.
- Knowledge of import/export regulations and global trade compliance.
- Extensive experience collaborating with and managing third-party CROs and CMOs.
Why Join This Innovative Team?
This role offers an exciting opportunity to make a significant impact within a collaborative, fast-paced biotech environment. If you're a proactive and adaptable leader with a passion for driving clinical supply chain excellence, we encourage you to apply.
