Apogee Therapeutics

Director

• Manage lifecycle of QC critical reagents and reference standards at all stages of product development
• Synchronize change management of critical reagents/materials and reference standards across multiple vendor sites in alignment with program team requirements
• Perform technical review of material qualification and re-evaluation protocols, reports, and analytical data received from vendors
• Coordinate QC material and sample shipments to support analytical testing activities at vendor sites
• Author controlled documents to support QC systems and infrastructure
• Overall responsibility for LIMS system administration for QC team
• Manage QC LIMS system changes, including updates to system master data (specifications, methods, reporting units) and workflows (automated data parsing/upload, data approval, reporting workflows)
• Support computer system validation and change control activities for LIMS system upgrades and enhancements in partnership with QA team and SaaS provider(s)
• Manage stability protocol configurations and updates in LIMS
• Collaborate with the vendor on on-going system issues, upgrades, and maintenance

Associate Director, QC Data and Materials Management

• Independently lead Clinical Pharmacology/PK/PD activities and provide scientific and strategic expertise to program teams, regulatory, and senior leaders to guide critical decisions and inform development plans
• Support pediatric development, including protocol development and dose selection.
• Develop and oversee implementation of clinical pharmacology studies from protocol development to final study reporting, in collaboration with cross-functional study team members, including Clinical Operations, Biometrics and Regulatory Affairs, as well as CRO partners
• Lead the analysis, interpretation, and reporting of clinical PK/PD data, author clinical study reports
• Develop and execute and/or oversee PK/PD modeling strategies to describe the relationship between drug exposure and response to support dose selection and overall development for clinical programs
• Provide clinical pharmacology timelines to program teams and negotiate with other functions on outcomes and deliverables to meet conflicting demands (time, cost, quality/performance)
• Lead authoring of clinical pharmacology sections of clinical and regulatory documents, including protocols investigator brochures, INDs, BLAs, and responses to regulatory agency comments
• Maintain a current understanding of PK and PD literature and methodology, as well as the scientific literature related to the emerging Apogee pipeline

Associate Director, QC Data and Materials Management

Director, Clinical Pharmacology