enGene

Supply Chain

• Build the Commercial Supply Chain Function
• Design and implement the commercial supply chain operating model.
• Establish demand planning, supply planning, inventory management, and S&OP processes.
• Define systems, tools, KPIs, and governance required to support launch and growth.
• Build and develop a scalable team aligned with anticipated commercial expansion.
• Lead cross-functional launch supply planning in partnership with Commercial, Regulatory, Quality, and Finance.
• Develop and execute launch readiness plans including labeling, packaging, serialization, distribution setup, and initial inventory build.
• Conduct scenario planning and supply risk assessments pre- and post-approval.
• Manage and oversee both Clinical & Commercial supply relationships with CMOs/CDMOs.
• Negotiate both clinical & commercial supply agreements and long-term capacity commitments.
• Implement performance metrics and governance processes with external partners.
• Ensure alignment between forecasted demand and manufacturing capacity.
• Design and qualify a compliant global distribution network.
• Oversee cold chain strategy, import/export processes, and GDP compliance.
• Select and manage 3PL providers.
• Implement inventory visibility and track-and-trace systems.
• Ensure commercial supply chain readiness for regulatory approval.
• Support regulatory submissions with supply chain documentation.
• Partner with Quality to ensure GMP/GDP compliance across external partners.
• Lead supply chain readiness for pre-approval inspections (PAIs).
• Develop and implement a supply risk management framework covering both clinical and commercial supply.
• Establish contingency plans for single-source suppliers.
• Lead supply continuity strategy during regulatory and launch transitions.
• Develop and manage the supply chain budget.
• Optimize working capital while maintaining service levels.
• Align supply strategy with gross margin and long-term profitability targets and drive strategic second source activation for supply security and cost reduction opportunities.

Head of Supply Chain

Data Scientist

• Provide scientific leadership across all clinical programs from early development through late‑stage global registrational trials.
• Oversee authorship, development, and strategic review of protocols, IBs, SAPs, CSRs, DSURs, ICFs, eCRFs, and clinical modules of major submissions.
• Lead global regulatory interactions (FDA, EMA, MHRA, PMDA), including briefing docs, written responses, and meeting preparations.
• Direct quantitative strategy across programs, integrating clinical data, real‑world evidence, model‑informed drug development, and exploratory biomarker analyses.
• Ensure robust data quality, oversee scientific data reviews, and resolve complex data issues.
• Lead scientific strategy for regulatory submissions (IND, CTA, BLA, MAA, sBLA/sNDA).
• Drive scientific publication strategy and represent the company in scientific forums.
• Provide leadership to Clinical Scientists, Statisticians, and cross‑functional partners.

Head of Supply Chain

Head of Clinical and Data Sciences