Key Responsibilities
- Lead cross-functional clinical supply chain teams to manage drug production planning and clinical supply chain execution, ensuring seamless provision of drug and ancillary supplies across the clinical portfolio.
- Set clinical supply chain strategy and strategic direction of supply for clinical programs.
- Lead Clinical Supply Chain Managers/Specialists for production, packaging, labeling, and distribution of drug supplies; align study supply strategies with business needs.
- Balance cost and risk to maximize supply efficiency.
- Aggregate clinical program supply demand and ensure inclusion in CMC and External Manufacturing supply planning.
- Create and implement a Clinical Supply Chain Program Strategy document; drive continuous improvement for scalability.
- Support supply requests for external sponsor studies, compassionate use, and access programs with cross-functional SMEs (e.g., Regulatory Sciences, Clinical Sciences, Commercial).
- Monitor and communicate spend vs. budget; lead Clinical Supply Chain/Finance review meetings and flag variances.
- Review vendor contract changes; manage procurement of IMP and ancillary materials (as applicable).
- Manage and review inventory levels at manufacturing facilities to meet demand.
- Support internal Quality Management compliance, including writing/reviewing SOPs; contribute to regulator/ethics submission documents.
- Contribute to/review supply and technical agreements with quality oversight; initiate Quality Events, perform root cause analysis, and execute CAPAs.
- Support selection of suppliers/CMOs, distribution depots, and contractors; drive procedural changes to improve SOP/regulatory compliance.
- Supervisory responsibility: may include line management; ensure deliverables/milestones are met with quality and on timeline.
Experience & Knowledge (Essential)
- Significant experience managing clinical supply chains.
- Project management; strong organization and attention to detail.
- Strong interpersonal skills and communication.
- Cold chain supply management and biopharmaceutical experience.
- Thorough understanding of GxPs and global clinical supply regulatory requirements.
- Experience working with technical systems; in a matrix environment.
- Budget management/forecasting; drug usage forecasting/supply and demand.
- Cross-functional project delivery experience; ability to work independently.
Experience & Knowledge (Desirable)
- Strong understanding of the drug development process.
- Technical experience delivering biopharmaceutical products to the clinic.
- Experience across all phases of clinical trials (including post-launch).
- Oncology therapeutic discipline knowledge.
Education & Qualifications
- Degree or higher in a relevant scientific subject or business management, or equivalent industry experience.
- Desirable: Masters or PhD in a relevant scientific subject.
- Proficient with Microsoft tools (MS Word, Excel, PowerPoint, Outlook, MS Project, SharePoint).