Director, Clinical Supplies (W2 Contract Role, NO H1B/OPT)

Greetings from IT Engagements Job Title: Director, Clinical Supplies (NO H1B/OPT) Location: Remote Req#: 36663167 Duties:

• Client is seeking an experienced and highly motivated individual to join our team as Director of Clinical Supply Chain Management to oversee the supply operations for our innovative clinical programs.
• The candidate will spearhead the setup and oversight of clinical supply chains for studies/programs spanning multiple phases.
• The candidate will be responsible for managing Interactive Response Technology (IRT) and drug distribution vendors for clinical trials including packaging, labeling, distribution, return, reconciliation and destruction activities, development of the Pharmacy Manual for clinical trial materials (Investigational Medicinal Product, IMP), and ensuring IMP is available at sites for dosing of patients during the study.
• The appropriate candidate should excel in working in a collaborative, fast-paced and cross-disciplinary biotech environment.
• The candidate must be a proactive, adaptable individual who excels in dynamic environments and can work autonomously.
• The Director will serve as the primary point of contact between various departments and external partners involved in ongoing and new clinical studies, including Tech Ops, QA, Regulatory, Clinical Operations, CROs, and CMOs.

Skills:

• Oversee clinical supply activities, encompassing label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management.
• Facilitate timely startup of new studies through prompt supply availability.
• Manage the Clinical Supply program for investigation drug product inventory management and distribution in partnership with CMOs; evaluates drug utilization versus forecast considering country requirements and logistical timelines.
• Responsible for the oversight of Clinical Supply CMOs.
• Responsible for the management of global strategies in IRT systems.
• Responsible for the creation, periodic review, and maintenance of all Clinical Supply SOPs.
• Accountable for initiating, overseeing, and resolving departmental deviations.

Collaborate with cross-functional teams (Clinical Operations, QA, CMC, and Regulatory) to ensure optimal execution of Clinical Supply strategy and identify and address potential risks to the progression of clinical programs proactively.

• Function as the internal point person for addressing product issues, temperature excursions, and deviations originating from clinical sites or depots. Collaborate with
• Quality Assurance to address any quality-related matters.

Serves as the primary representative/subject matter expert (SME) during all inspections and clinical supply chain audits.

• Serve as a subject matter expert and devise continuous improvement plans for clinical supply GMP, GDP, and business processes.
• Assist in ongoing drug accountability and reconcile end-of-study drug inventory.

Provide clinical supply and risk mitigation recommendations.

• Oversee inventory management of study drug and comparators at depots.
• Mentor CSC team members as needed on programs and systems.

Keywords: Education:

• B.S. in a scientific, healthcare, or related field with 10+ years of global clinical supply chain experience within the biotechnology sector. APICS certification is advantageous.
• Proven history of establishing, refining, and managing clinical supply chains within the biotechnology industry.
• Solid understanding of GMPs, GCPs, GDPs (GxP) requirements
• Strong attention to detail with excellent follow-up.
• Progressive knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance.
• Previous successful collaboration & management of third-party CRO's and CMO clinical supply operations.
• Strong experience of GxP & Systems including development of specifications, oversight of system operations, troubleshooting & identifying gaps, performing set-up & testing of systems, & understanding areas of limitations, risks, or gaps to mitigate. (IRT).
• Exceptional written and verbal communication, with diligence, collaboration, ability to manage complex challenges, and influencing skills.
• Excellent planning, organizational skills, and the ability to work simultaneously on multiple projects with tight timelines.
• Experienced in assisting, as the Clinical Supply Chain SME, during Regulatory Inspections and Audits.
• Proactive in driving performance cross-functionally and fostering collaboration.

Ability to build/drive internal team consensus.

• Translates broad strategies into specific objectives and action plans.
• Proficient knowledge of MS Office (Smartsheet, Excel, PowerPoint, Visio, Project, etc.)

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