Enliven Therapeutics

Director

• Oversee late-stage drug substance/API development and manufacturing activities to support pivotal studies, regulatory submission, and commercial launch readiness
• Help define and execute phase-appropriate API strategy for late-stage development, ensuring alignment with program milestones and submission goals
• Ensure process design and control strategy are sufficiently established to support pivotal trials, registration, and commercial manufacturing readiness
• Oversee external CDMO/CMO activities for late-stage API manufacturing, process performance, and supply continuity
• Lead technology transfer activities between manufacturing sites to support scale-up, validation, and long-term commercial supply
• Drive process characterization, CPP identification, validation planning, and PPQ readiness/execution for late-stage programs
• Establish, maintain, and refine API control strategy, specifications, and supporting documentation for regulatory submission and commercial readiness
• Oversee drug substance manufacturing campaigns, scheduling, site readiness, and operational execution to ensure timely supply for clinical and registration-enabling activities
• Author, review, and approve technical reports and GMP documentation, including batch records, protocols, specifications, campaign reports, and regulatory CMC submission content
• Partner closely with Quality, Regulatory CMC, Supply Chain, Analytical, Formulation, Legal, and external manufacturers to ensure cGMP compliance, inspection readiness, and successful health authority interactions
• Help represent CMC/DS/API needs to core development team

Director, Process Chemistry

• Responsible for the preparation of the clinical pharmacology sections of early and late-stage clinical protocols
• Contribute to the preparation of the IND, IB and IMPD documents
• Be able to conduct noncompartmental PK analysis based on preliminary data using standard industry data analysis software
• Contribute to the design of early phase clinical trials (FIH to POC)
• Contract and monitor CRO for clinical pharmacology projects, such as popPKPD analysis, clinical pharmacology studies
• Represents the Clin Pharm function in project teams
• Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions.

Director, Process Chemistry

Associate Director, Clinical Pharmacology