Description
The Study Supply Manager will support Radioconjugates clinical studies, collaborating with Global Study Teams and external vendors to ensure clinical drug product needs are met across multiple programs.
This role builds strong relationships, acts as a key resource and escalation point, and contributes to the creation of strategy for clinical drug supply, translating strategic objectives into clear, actionable plans.
Working both within clinical drug supply and cross-functionally, the Study Supply Manager helps develop consistent practices, routinely identifies risks in the supply chain, recommends mitigation plans to management, and implements effective solutions.
Key responsibilities include:
- Developing and maintaining strong, collaborative relationships with key stakeholders across Global Study Teams, Quality, Radiation Science and CMC, ensuring alignment on study needs and timelines.
- Ensuring key project milestones are met by defining, negotiating and communicating clinical supply plan timelines to internal and external stakeholders and partners.
- Serving as an escalation point to Clinical Logistics, Clinical Operations, CMC and/or CROs, resolving issues quickly and effectively.
- Participating in functional initiatives, including process development and review, and system/process improvement to drive operational excellence.
- Supporting the creation and maintenance of Radioconjugates pharmacy manuals to enable safe and compliant handling at clinical sites.
- Overseeing ordering, tracking, delivery and receipt of clinical supplies and drug to clinical sites, ensuring availability for patients when needed.
- Leading monthly network capacity planning so that supply plans are aligned with clinical programs, manufacturing schedules and quality capabilities.
- Collaborating with Radio Pharm Manufacturing and Quality to manage any issues arising during shipping and/or receipt, communicating delays to the clinical team and, when applicable, managing deviations and corrective/preventive actions.
- Continuously monitoring supply chain risks across multiple programs, proposing mitigation strategies and implementing agreed actions to protect study continuity.
Essential skills and experience include:
- Bachelor’s Degree with 5+ years of experience with clinical supply chain, Phase I-III.
- Knowledge of ICH GCP Guidelines and local and international regulatory requirements.
- Demand planning, forecasting and analytical skills.
- Advanced problem-solving ability.
- Flexibility in working hours to deal with Global supply activities.
- Excellent written, verbal and interpersonal communication skills and comfort working with multiple internal and external stakeholders.
Desirable skills and experience include:
- Certification in Supply Chain and Operations Management (i.e. – CSCP, CPIM).
- Prior experience in radiopharmaceutical/pharmaceutical product distribution of Class 7 Dangerous goods including import/export.