Enliven Therapeutics

• Lead execution of pivotal clinical trials • Serve as Study Responsible Physician and provide medical oversight for one or more Phase 3 clinical studies supporting the late-stage development of ELVN-001. • Provide leadership, mentoring, and oversight to clinical scientists across assigned studies and development activities. • Partner cross-functionally with Clinical Operations, Biostatistics, Clinical Pharmacology, Regulatory Affairs, Translational Sciences, Data Management, and other functions to ensure high-quality and timely study execution. • Contribute to the design, conduct, analysis, and interpretation of late-stage oncology clinical trials. • Lead ongoing medical monitoring activities, including safety review, data interpretation, benefit-risk evaluation, protocol deviation review, and endpoint adjudication. • Collaborate with clinical scientists and cross-functional partners on: Preparation and review of clinical study documents, including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. Medical review of clinical data and support of data review activities. Preparation and presentation of clinical data for internal governance meetings, investigator meetings, scientific congresses, and external stakeholder interactions. Development of study-related training materials and investigator communications. Support regulatory submissions and responses to Health Authority and Ethics Committee inquiries. Build and maintain relationships with clinical investigators, cooperative groups, and Key Opinion Leaders. Contribute to registrational clinical development strategy, Phase 3 execution, commercialization planning and lifecycle planning for oncology programs. Participate in preparation of scientific publications, abstracts, and presentations. Review and synthesize relevant scientific and medical literature to support program strategy and competitive awareness. Support broader clinical development and medical affairs initiatives as needed.

• 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

• 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.

• Lead the strategic and operational oversight of all clinical and nonclinical biosample activities across the company’s development pipeline. • Building and managing end-to-end sample lifecycle processes—including collection, logistics, chain of custody, tracking, biobanking, vendor oversight, and data reconciliation. • Develop and execute the company’s global biosample management strategy across all clinical programs. • Establish scalable sample governance frameworks suitable for a small but fast-growing biotech environment. • Serve as the subject-matter expert for biospecimen regulations, GCP/GCLP standards, and evolving global requirements. • Ensure robust chain-of-custody and sample traceability systems. • Design and maintain sample management plans, laboratory manuals, and related documentation. • Partner with Translational Medicine/Research to enable biomarker strategies, assay development, and laboratory readiness. • Work with Clinical Operations to incorporate sample needs into protocol design, site training, and monitoring. • Support Biometrics and Data Management in reconciling sample data with clinical datasets. • Identify, select, and manage CROs, central labs, specialty labs, and biorepositories. • Negotiate scopes of work and oversee budget, performance metrics, and quality compliance. • Implement and monitor KPIs, SLAs, and corrective action plans when needed. • Implement or optimize LIMS/sample-tracking systems appropriate for a small biotech. • Drive continuous improvement initiatives to streamline workflows and enhance sample, visibility. • Establish and maintain SOPs, work instructions, and forms related to biosample handling. • Ensure compliance with ICH/GCP, GCLP, CLIA, CAP, GDPR, and relevant global biospecimen regulations. • Support regulatory submissions (e.g., IND, CTA, BLA) with sample-related documentation. • Prepare for and support audits and inspections related to biospecimen management. • Build and lead a high-performing biosample management team as the company grows. • Provide coaching, resource planning, and professional development for direct reports.