Clinical Supplies Manager

THIS POSITION WILL BE ON-SITE IN ONE OF THE FOLLOWING LOCATIONS: San Francisco Bay Area / Dallas, TX / Miami, FL / Princeton, New Jersey

Overview of Role:

We are seeking an experienced clinical supplies professional to join the CMC team and support the supply chain strategy for clinical development and commercialization preparations.
The Clinical Supply Chain Manager will be responsible for managing the planning and execution of assigned clinical supply projects and to support the ongoing development pipeline and optimization of Clinical Supplies department processes.

The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key supply chain expert for cross functional teams. Prior experience in a small to mid-sized, fast-growing pharmaceutical environment is preferred.
Summit is a global company; overseeing global activities across multiple time zones and as such may require flexibility in working hours at times. Travelling for the role (vendor facility visits, Investigator Meetings, etc.) will be required at times and is estimated to be 5-10%.

Role and Responsibilities

• Clinical Trial Supply Chain Planning and Forecasting
  • Develop and maintain accurate forecasts for clinical trial supplies based on protocol requirements and enrolment projections.
  • Collaborate with cross-functional teams to ensure alignment of clinical trial supply plans with study timelines and milestones.
• Vendor Management
  • Oversee relationships with external vendors, including clinical packaging and labelling partners, distribution centers, and courier services.
  • Monitor vendor performance, adherence to timelines, and quality standards.
• Inventory Management
  • Implement and maintain robust inventory management systems to track and manage clinical trial supplies throughout the supply chain.
  • Ensure adequate and timely supply of investigational products to clinical sites.
  • Oversee the planning, implementation and utilization of effective clinical systems to support inventory management and distribution (e.g. IxRT).
• Regulatory Compliance
  • Stay up to date on relevant regulatory requirements and guidelines related to clinical supply chain management.
  • Support regulatory strategy by overseeing provision of required documentation for submission and QP certification as required.
  • Ensure all activities comply with Good Manufacturing Practice (GMP) and other applicable regulations.
• Risk Management
  • Identify potential risks and challenges in the clinical supply chain and develop mitigation plans.
  • Proactively address issues that may impact the availability of clinical trial materials.
• Communication and Collaboration
  • Foster effective communication and collaboration with internal stakeholders, including Clinical Operations, Regulatory Affairs, Quality Assurance, and other relevant departments.
  • Participate in project team meetings to provide updates on clinical supply chain status and address any issues or concerns.
  • Contribute to monthly review cycles to ensure cross functional alignment on strategic and tactical topics.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's degree in a relevant scientific or business discipline; advanced degree preferred.
• Minimum 5+ years’ experience in Supplies management at a pharma, biotech or contract development and manufacturing organization (CDMO)
• Proficiency in relevant software applications (e.g., Microsoft Office, clinical trial management systems)
• Demonstrated track record of successfully managing complex international clinical studies and supply chains
• Broad understanding of regulatory and GMP requirements for IMP product packaging and supply
• Solid understanding and experience in design specifications and UAT of IXRS applications
• Project management skills, tools, principles, and applications
• Expertise in outsourcing and supplier management
• Proficiency with clinical supply planning and forecasting tools
• Demonstrated experience in building out an end-to-end product supply chain
• Comfortable interacting with all levels of the organization, customers, and suppliers
• Able to work with abstract global problems
• Nimble in a highly dynamic and agile organization where changing priorities are the norm
• Intuitive with well-honed interpersonal and communication skills