Apogee Therapeutics

Supply Chain

• Maintain inventory oversight of applicable drug supply (Cell Banks (CB), Drug Substance (DS) and Drug Product (DP)) in collaboration with other functions in Development, Manufacturing & Supply (DMS)
• Support logistics execution and oversight of DS and DP supply with other trade compliance activities as needed
• Assist with assembly of bulk devices and allocation across studies as applicable
• Develop and execute Demand & Operations Planning (D&OP) with Supply Chain Management team and other cross-functional members, such as Clinical Operations and Manufacturing
• Utilize forecasting tools to develop clinical supply forecasts to enable supply planning per assigned studies and/or bulk supply across studies
• Develop packaging and supply strategies to meet clinical study needs, maximize supply efficiency, and minimize waste while maintaining a low risk profile
• Clearly communicate expiry requirements based on labeling strategy and supply plans with Analytical Development
• Represent Apogee with selected external providers to develop project requirements and provide project management oversight during planning and execution
• Manage oversight of packaging and labeling jobs for assigned studies in collaboration with GMP Quality Assurance
• Develop requests for proposals for labeling, packaging, storage, and distribution; analyze quotes from prospective providers and make recommendations to management
• Review vendor invoices and provide input for accruals and budget as applicable
• Coordinate US and international distribution and logistics for clinical studies based on supply plans
• Drive development of Interactive Response Technology (IRT) user requirement specifications and acceptance testing
• Develop and provide input for SOP’s and work instructions required to optimize Supply Chain operations
• Maintain Supply Chain Management metrics and KPIs to support internal reporting and external reporting for vendor oversight/governance

Supply Chain Manager

Clinical Operations

• Collaborate with business partners to research and evaluate potential vendors based on their capabilities, pricing, and service level agreements
• Build strong relationships with key vendors
• Conduct ongoing assessment of vendor relationship performance through KPI review, vendor performance trend analysis, and administration/interpretation of stakeholder satisfaction surveys
• Drive and improve existing systems and processes
• Maintain knowledge of market trends for assigned key vendors
• Lead and conduct high visibility and competitive negotiations
• Support sourcing policies, contingency plans, and additional strategic initiatives established by the Vendor Strategy & Management Lead
• Support Clinical Operations Vendor Sourcing and vendor governance related meetings
• Hold vendors accountable to performance goals/agreements
• Drive annual third-party vendor spend savings while improving processes and vendor relationships
• Closely manage deliverable timelines and cross-functional input to keep reviews, decisions, and initiatives on track
• Participate in the continuous improvement process for programs within purview
• Lead/participate in vendor strategy and budget discussions
• Collaborate on contracts review to verify compliance with MSA, discount structures, and performance requirements

Clinical Operations Vendor Manager

Director

• We are seeking an Associate Director, Clinical Programming, to join the Data Management team.
• In this position you will be responsible for both managing and analyzing clinical trial data using programming languages like SAS, R, and Python to ensure data integrity, generate tables and figures, and support regulatory submissions.
• Key responsibilities include data cleaning, developing statistical programs, creating reports, validating outputs, and collaborating with statisticians and data managers to assess drug safety and efficacy.
• Ensure compliance with CDISC standards and regulatory guidelines to support decision-making.

Associate Director, Clinical Programming

• 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

Director, Clinical Pharmacology

• 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

Supply Chain Manager

Clinical Operations Vendor Manager

Associate Director, Clinical Programming

Director, Clinical Pharmacology

Associate Director, QC Data and Materials Management