Head of Clinical Supply Chain

About the role

We are seeking a Head of Clinical Supply Chain to be part of our Technical Operations team. This individual will lead and build the clinical supply chain team and manage end-to-end clinical supply activities for our early and late-stage programs. This position will design, develop, and implement clinical supplies strategies to ensure appropriate continuous supply of material. The successful candidate will work closely with Technical Operations, Clinical Operations, Quality Assurance, Regulatory Affairs, and third-party CMOs.

Responsibilities

• Provide strategic and operational oversight of Treeline’s clinical supply chain operation
• Ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements
• Responsible for all levels of studies, from simple, early-phase programs to complex, multinational, multi-arm studies.
• Develop clinical supply forecasts, packaging / labeling requirements, and distribution / return operations in close collaboration with CMC, Clinical Operations, Quality, and Regulatory
• Lead and manage external consultants and third-party vendors, including collaborating with QA on vendor selection and quality and supplier agreement development.
• Provides proactive risk identification and mitigation strategies for clinical supply chain.
• Identify and directly manage third party vendors for clinical product storage and distribution both within the US and internationally.
• Lead contract negotiation activities from a technical perspective for clinical supply chain vendors
• In compliance with global regulations, ensure the development and implementation of robust supply chain processes to ensure clinical supply continuity.
• Lead sourcing & distribution of comparator drugs, and matching placebo as needed.
• Support regulatory filings on an as needed basis.
• Effectively communicate progress to internal management and external CDMO partners
• Import / export experience in support of international clinical trials a plus
• Coordinate primary and secondary packaging, labeling, testing, distribution and return drug management activities with CMO's.
• Interface with QA, RA, CMC/manufacturing to ensure trial supplies are appropriately supported including shelf life, quantities, country approvals and specification.
• Develop and manage forecasting and ordering of commercial comparator/combination supplies for global trials
• Proactively find solutions to emerging issues in an effective manner while taking into consideration risks and cost-effectiveness.
• Develop new functional SOPs, Policies/Plans as necessary

Required Qualifications

• Bachelor’s degree in supply chain, life sciences, or a related field with 12 + years of experience in clinical supply chain management in the pharmaceutical industry supporting global clinical trials
• Demonstrated ability to build and develop a clinical supply chain function in an emerging pharmaceutical company
• Experience working with third party vendors for IRT setup, IMP storage, and distribution both within the US and internationally.
• In depth knowledge of GMP and global Health Authority requirements.
• Comprehensive knowledge of IRT design and management to support clinical supply planning.
• In-depth understanding of medication management and use of advanced simulation tools
• Demonstrated ability to hire, mentor and develop supply chain managers.
• Excellent cross-functional team leadership and project management and presentation skills
• High level of adaptability in a dynamic and fast-paced environment. Ability to adjust strategies, priorities, and processes in response to changing project needs or stakeholder expectations
• Understanding of budgeting processes and ability to analyze cost effectiveness when defining supply strategies
• Demonstrated ability to interpret clinical trial drug requests and protocol requirements and translate these into clinical packaging strategies, timelines, and budgets
• Collaborative leader who can influence both business and external partners
• Excellent verbal and written communication skills, with the ability to build productive long-term team relationships at all levels of supplier organizations
• Willingness to travel to various meetings or client sites, domestically or internationally.