Manager, Clinical Supply Chain

The Manager, Clinical Supply Chain is responsible for overseeing and managing the end-to-end supply chain activities related to clinical trials, clinical dose ordering, and the distribution of radiopharmaceutical products. You will collaborate closely with cross-functional teams, including Clinical Operations, Quality, Regulatory, Manufacturing, and Logistics, to ensure the efficient and timely delivery of clinical supplies while adhering to regulatory requirements and company standards.

Key Accountabilities:

Collaborate with cross-functional teams to establish and maintain effective relations with clinical sites, CMOs, and third-party logistics providers, ensuring the timely and accurate order placement and delivery of clinical supplies.
Collaborate with logistics team to identify lane mapping for clinical study sites in new regions.
Organize clinical mock shipments to any new regions as required by program/study.
Review and analyze clinical dose orders and status’ on a regular basis, capturing any impact notes to the dose as required.
Coordinate implementation of investigational product labeling with approved label provided by Telix GRA, assist with packaging, and distribution activities, ensuring compliance with regulatory guidelines and internal quality standards.
Collaborate with Regulatory and Quality teams to ensure compliance with all relevant regulations, guidelines, and standards governing clinical supply chain operations.
Proactively identify and mitigate potential supply chain risks and develop contingency plans to address any potential disruptions to the clinical supply chain.
Develops program models, contributes to the study specifications for studies, and provides investigational medicinal
product management for highly complex studies.
Contribute to creation of product and study specific IMP Handling manuals with Clinical Operations team.
Track and analyze key supply chain metrics and performance indicators, providing regular reports and recommendations for process improvements and cost optimization.
Stay up to date on industry best practices, trends, and emerging technologies in clinical supply chain management, and incorporate relevant advancements into the company’s supply chain strategies and operations.

Education and Experience:

Bachelors degree in Business, supply chain or related field or 8+ years of radiopharma experience.
Inventory management, packaging, labeling, and distribution experience in pharmaceuticals or highly regulated industry a plus.
Coordinate and share investigational product labeling with CMO for each clinical product and region-specific label approved by GRA, assist with packaging sourcing if needed, and distribution activities, ensuring compliance with regulatoryguidelines and internal quality standards.
Collaborate with Regulatory and Quality teams to ensure compliance with all relevant regulations, guidelines, and standards governing clinical supply chain operations.
Proactively identify and mitigate potential supply chain risks and develop contingency plans to address any potential disruptions to the clinical supply chain.
Track and analyze key supply chain metrics and performance indicators, providing regular reports and recommendations for process improvements and cost optimization.
Stay updated on industry best practices, trends, and emerging technologies in clinical supply chain management, andincorporate relevant advancements into the company’s supply chain strategies and operations.

Key Capabilities:

Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills