Senior CMC Development Consultant

Job Summary

To support the development of a comprehensive Product Development Roadmap, the part-time Senior CMC Product Development Strategy Consultant will design governance frameworks and facilitate workshops with senior leadership, primarily working remotely with occasional onsite engagements.

Key responsibilities

• Lead the design of a comprehensive Product Development Roadmap (PDR) framework covering all development stages from discovery to commercial launch readiness
• Develop an enterprise playbook that defines stage gates, governance models, key activities, and decision criteria for product development
• Facilitate workshops with senior leadership to align on the roadmap structure and governance approach while identifying best practices from leading pharmaceutical organizations

Required qualifications

• 15+ years of progressive experience in pharmaceutical or biotechnology sectors, with significant leadership in CMC Development and Product Development
• Proven experience in building stage-gate processes and governance models for product development
• Strong understanding of the CMC development lifecycle, IND-enabling activities, and regulatory submission requirements
• Experience facilitating executive workshops and achieving cross-functional alignment
• Background in supporting products from early development through regulatory submission