Clinical Supplies Manager

Summit Therapeutics Sub, Inc.; Miami (FL); On-site; USD 130,000 - 150,000; Full time

Job summary

An established industry player is seeking a Clinical Supply Chain Manager to join their dynamic CMC team. In this pivotal role, you will manage the planning and execution of clinical supply projects, ensuring alignment with study timelines while overseeing vendor relationships and regulatory compliance. This position offers a unique opportunity to contribute to the ongoing development pipeline in a fast-paced pharmaceutical environment. If you thrive in collaborative settings and are ready to tackle complex challenges, this role is perfect for you. Join a global company that values innovation and teamwork, where your expertise will make a significant impact on clinical development and commercialization preparations.

Qualifications

• 5+ years of experience in supplies management in pharma or biotech.
• Proficiency in supply chain planning and forecasting tools.

Responsibilities

• Manage planning and execution of clinical supply projects.
• Oversee relationships with external vendors and monitor performance.
• Ensure compliance with regulatory requirements and GMP.

Skills

Supply Chain Management

Regulatory Compliance

Project Management

Communication Skills

Inventory Management

Collaboration

Problem-Solving

Interpersonal Skills

Education

Bachelor's degree in a relevant scientific or business discipline

Advanced degree preferred

Tools

Microsoft Office

Clinical Trial Management Systems

IXRS applications

Job description

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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.
• 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.
• 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
• 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

The pay range for this role is $130,000 - $150,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.