Director

• Direct the CMC drug substance development and manufacturing activities within Elevar’s portfolio by providing scientific and technical leadership, including oversight of multiple projects at various stages of the drug development life cycle from late-phase clinical studies, through filing/launch and sustained supply
• Lead and contribute to the strategy, planning, execution, and progress reporting for development projects as well as commercial products
• Identify, evaluate, select, and develop relationships and actively manage external partners (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets, and timelines.
• Ensure processes are in line with health, safety, environmental, and quality requirements, including regulations, policies, applicable guidelines, and practices
• Develop and provide high-level guidance to senior management on CMC requirements and generate project and resource plans for company drug substance development
• Author and update CMC documents suitable for regulatory filings (IND’s, IMPD’s, NDA’s, MAA’s, etc.)
• Efficiently support cross-functional project teams
• Coordinate drug substance activities with analytical and drug product development teams within CMC
• Understand and support the needs and requirements from other functional groups including toxicology, pharmacokinetics, and regulatory
• Provide updates to project and management teams

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