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