Responsibilities:
- Define and implement clinical supply chain strategy aligned with CSC KPIs and project objectives.
- Assess study design feasibility (ID study card, Abbreviated Protocol stages) and optimize project delivery.
- Influence Label & Pack outsourcing and distribution network strategy decisions.
- Monitor supply chain performance (cost, lead times, quality) using KPIs and digital tools.
- Drive continuous improvement and innovation across clinical supply chain operations.
- Lead CSC-Study Leaders and oversee operational activities ensuring compliance with GCP/GMP standards.
- Ensure CSC strategy harmonization across multiple trials while adhering to timelines and budget.
- 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 the project team and coordinate PAI preparation.
- Provide CSC expertise for project decision-making; escalate IMP/device/AxMP/comparator issues and propose mitigation.
- Interact with GPH, CMC leaders, and Clinical leaders to integrate CSC requirements into project strategy.
- Report progress/issues to CSC Leadership Team; facilitate knowledge sharing and provide feedback on contractor performance.
Qualifications:
- Bachelorโs degree with 5+ years OR Masterโs degree with 3+ years in Health Sciences or related disciplines (Engineering, Pharmacy, Chemistry, Biology, etc.).
- Experience in the pharmaceutical industry, preferably clinical supply chain, clinical operations, or manufacturing.
- Project Management experience.
Preferred:
- Experience with GxP regulations and IMP requirements.
- Experience with N-SIDE forecasting systems and/or IRT systems.
- Risk management experience.
Skills:
- Leadership, cross-functional collaboration, strong prioritization and problem-solving.
- Excellent written/oral communication, negotiation, and influencing.
- Ability to build relationships in complex, cross-cultural environments.
Benefits (explicitly stated):
- Health and wellbeing benefits, including at least 14 weeksโ gender-neutral parental leave.