Clinical Supplies Manager

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.
The Clinical Supply Manager will be responsible for planning and execution of operations for their assigned clinical supply projects and to support the ongoing development pipeline as well as 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-paced pharmaceutical environment is preferred.
Summit are 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 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 centres, 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 utilisation 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
• Successful candidate will be:
  • 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
  • Organized and demonstrates effective team leadership
  • Effective with global workgroup associates
  • A promotor of inclusion and collaboration
  • Able to work independently
  • Able to handle multiple projects simultaneously while maintaining high-quality results
  • Capable of providing and implementing innovative solutions to unique and pressing situations
  • Aware and compliant with FDA, EMA, PMDA regulations and requirements for functioning under GMP, GCPs, Annex 13, and EU CT Directive/Regulation
  • Able to demonstrate a fundamental knowledge of drug development process
  • Technically proficient in industry standard technology and/or available software, processes, and industry trends to streamline and or improve efficiencies
  • Knowledgeable of and compliant with SOPs, Change Controls, Deviations, Investigations and CAPAs