SRG, the leader in the Life Sciences human capital industry, is looking for a full-time contract Global Clinical Supply Lead in Fort Collins or Denver, Co. *This position has the option to be a hybrid or remote role. This role will act as the technical lead, managing the supply of internal clinical trial medications for CMC (Chemistry, Manufacturing and Controls) globally. As part of the Clinical Study Protocol development team you will interpret clinical trial protocols for the study drug requirements (investigational Medicinal Product (IMP) and commercially sourced) for the proposed study design, understand the requirements for packaging and labelling, ensure all labelling regulations are met for countries involved. Managing responsibilities include coordinating between Global Medicines Development (GMD), R&D CMC, Commercial Supply and Quality Assurance (R&D QA) to deliver the IMP to support study timelines.

JOB RESPONSIBILITIES include, but are not limited to:

• Ensure sufficient supply of study drug is available to supply all clinical study timelines.
• Engage and manage appropriate 3^rd parties (in coordination with commercial supply, as needed) as necessary to perform GMP clinical drug assembly labelling and release
• Advise on clinical site logistics and handling including storage conditions and required capacities, as applicable.
• Provide content for study related documents for IMP, for example, pharmacy manuals, training slides for Investigator meetings, site initiation visits, etc.
• Manages the logistic activities of global project(s) clinical supply chain including initiating and managing all GMP bulk shipments across the supply chain (API, drug product, finished goods).
• Manage the shipment of IMP including the coordination of import / export documentation meeting national requirements
• Ensure all required documentation gathered and supplied to the CPM to complete the Clinical Study Greenlight release process.
• Periodic SOP review and editing and workflow management for alignment with optimal clinical supply chain processes and regulatory compliance.
• Authoring change controls, risk assessments, deviations, etc., as needed to support clinical supply processes

WHAT YOU NEED TO HAVE:

• A degree in science or other relevant discipline.
• 5+ years' experience in pharmaceutical drug development; experience with addiction therapy preferred from phase I clinical trials through to commercialization.
• Strong understanding of global pharmaceutical regulations.
• Proven experience and practical knowledge of Drug Development, GLP, GMP Manufacturing, 1°, 2°, 3°Packaging, and Labelling, Clinical Patient Pack design.
• Experience and understanding of global cGMPs and regulations regarding the supply and release of clinical trial drugs.
• Management experience with 3^rd parties, global regulatory, local regulatory, QA, Supply Procurement and Supply Manufacturing and other relevant functions to deliver projects.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.