Clinical Supply Chain Project Leader
TalentAlly · Cambridge, MA · Yesterday
HybridFull-time
About the role
The Clinical Supply Chain Project Leader (CSC-PL) is accountable for IMP supply with respect to timelines, quality and budget for a given project. The CSC-PL is responsible to:
- Defines and implements the CSC Strategy at project level.
- Oversees study management activities ensuring adherence to plan.
- Represents CSC at project level.
Main responsibilities
- CSC Strategy & Implementation
- Define and implement clinical supply chain strategy aligned with CSC KPIs and project objectives
- Audit study design feasibility (ID study card, Abbreviated Protocol stages) and optimize project delivery
- Influence Label &Pack outsourcing and distribution network strategy decisions
- Maintain supply chain performance (cost, lead times, quality) using KPIs and digital tools
- Drive continuous improvement and innovation across clinical supply chain operations
Study Management Oversight
- Lead CSC-Study Leaders and oversee all operational activities ensuring compliance with GCP/GMP standards
- Monitor plan execution, identify risks, and implement mitigation plans
- Identify opportunities to streamline processes and reduce lead times and costs
- Serve as primary point of contact for project team and coordinate PAI preparation
CSC Representation & Stakeholder Communication
- Provide CSC expertise and contribute to project decision-making in project meetings
- Escalate IMP/device/AxMP/comparator issues and propose mitigation strategies
- Interact with GPH, CMC leaders, and Clinical leaders to integrate CSC requirements into project strategy
- Report Progress and issues to CSC Leadership Team
- Facilitate knowledge sharing and provide feedback on contractor performance
About You
- Education: Bachelor's degree with at least 5+ years OR Master's degree with at least 3+ years preferably in Health Sciences or related disciplines (Engineering, Pharmacy, Chemistry, Biology, etc.)
- Experience & Technical Skills: Experience in pharmaceutical industry, preferably within clinical supply chain, clinical operations, or manufacturing environments. Project Management experience
- Preferred Qualifications: Experience with GxP regulations and IMP requirements. Any experience with N-SIDE forecasting systems, IRT systems preferred. Risk management experience.
- Soft Skills: Demonstrated leadership experience in engaging and ensuring collaboration across different functions. Excellent workload prioritization within a dynamic, timeline-driven, culturally diverse organization. Advanced organizational, planning, and prioritization skills with effective problem-solving and decision-making abilities. Excellent communication (written and oral), negotiation, and influencing skills. Ability to build and maintain efficient professional relationships with partners and stakeholders. Experience operating in cross-cultural and complex organizational matrices. Self-driven with effective time management skills.