The Sr. Manager / Associate Director, Clinical Supply Chain Management will manage global supply chain and distribution of drug products for all on-going and new clinical programs at the company. This individual will oversee supply chain management activities including: planning and coordinating packaging, labeling, distribution, reconciliation, and destruction of drug product for clinical studies. The Sr. Manager / Associate Director will interface between clinical, CMC and external CROs to actively develop and manage process ensuring timely, accurate and continuous supply to patients while reducing risk and minimizing waste.
- Work with Clinical Operations to understand clinical demand requirements and ensure alignment with CMC to supply plans and timelines
- Manage GMP inventory (both drug product and drug substance) throughout the supply chain, develop inventory reports, manage upcoming expiry and temperature excursions, and ensure drug accountability
- Support the evaluation, selection and quality audit of packaging/labeling and distribution vendors
- Coordinate daily activities with distribution vendors as required
- Serve as internal lead for triaging of product complaints, temperature excursions, and deviations originating from distribution vendors and clinical sites.
- Investigate deviations to determine root causes and implement corrective actions
- Ensure label text and proofs are in accordance with applicable regulations, product specifications, and clinical study protocols
- Support IRT user acceptance testing, supply strategy, and oversee ongoing supply activities in system
- Coordinate import/export activities and track shipments to depots and clinical sites.
- Ensure all necessary documentations are available to the clinical sites
- Develop supply chain management strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Work with QA/QC to establish internal SOPs for supply chain management related activities
- M.S. or B.S in scientific or health related field with 8+ years’ experience in Clinical Supply Chain Management in biotech or pharmaceutical industry
- Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP)
- Knowledge of IWRS/IRT system setup and functionality and proficiency with Excel modeling
- Knowledge and understanding of international pharmaceuticals shipping requirements
- Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Effective communication, interpersonal skills, collaboration and negotiation skills
- Highly organized and efficient, able to orchestrate multiple projects simultaneously