Sr Clinical Supply Manager

Job DescriptionReporting to the Associate Director of Supply Chain, this individual will serve as an integral team member with exposure to multiple facets of business operations. The Senior Manager Clinical Supply Chain will be responsible for the global supply and distribution of investigational drug product for Company’s ongoing clinical trials inclusive of the oversight management of Contract Manufacturing Organizations (CMOs) and distribution providers. The ideal candidate must work closely with the Clinical Operations and Quality Assurance teams. Additional features of the position include responsibility for IRT system ownership.Major Duties/Responsibilities

• · Lead clinical supply chain activities including, but not limited to, protocol interpretation, distribution, 3PL inventory management, label generation and oversight of packaging/labeling and distribution activities.
• · Work collaboratively with cross-functional members of Clinical Development and Supply Chain to develop optimal supply Finished Goods strategies and ensure timely supply to patients while reducing risk and minimizing waste.
• · Coordinates the day-to-day fulfillment of drug shipment requests for all products under clinical development in a cost-effective manner and in compliance with cGMP requirements.
• · Develops and maintains forecasts for clinical trial materials, aligning expectations and activities with cross-functional team.
• · Manage GMP inventory (drug product, finished product) throughout the 3PL network to ensure appropriate inventory levels are maintained.
• · Support import/export activities and track shipments to depots and clinical sites.
• · Manage return and destruction of clinical supplies, with proper documentation of all steps.
• · Collaborates with team to understand the product stability data and define acceptable practices and procedures for handling any excursions or deviations from recommended storage and handling conditions. Resolves excursions or deviations in collaboration with Quality Assurance and facilitates supply management at the clinical sites, defines and implements corrective/preventive actions to minimize the occurrence of such excursions or deviations.
• · Plan over-labeling of study drug at depots/sites with appropriate lead time.
• · Develop a labeling strategy that meets regulatory and study requirements.
• · Lead the development and approval of label text and label proofs including country-specific translations, as applicable.
• · Works closely with Clinical Operations supporting in design, development, implementation, and maintenance of IRT systems. Identify risks throughout the supply chain and implement risk mitigation plans.
• · Manage IRT vendor(s), ensuring system design requirements are fulfilled for each study and break/fix issues are tracked and managed in a timely manner.
• · Prepare SOW’s and associated purchase requisitions to meet project requirements and timelines.
• · Manage 3PL work/change order issuance and budget adherence.
• · Support preparation of clinical study manuals/documents including applicable content within the pharmacy manual.
• · Drive continuous improvement and innovation in clinical systems and processes with the objective of enhancing quality, productivity, costs, and efficiency.

Education & Professional Experience
Required:

• · Minimum 6+ years in bio/pharmaceutical industry, or combination of education and experience.
• · Working knowledge of current GMP/GCP/GDP regulations.
• · Experience in forecasting, demand / supply planning, IRT systems, inventory management, clinical packaging/labeling and distribution including cold chain, import/export and reverse logistics.
• · Experience in managing outsourced business partners, including 3rd party manufacturing, packaging, warehousing & distribution