Apogee Therapeutics

Director

• Support the statistical programming function by implementing programming processes, standards, and SOPs for clinical trials
• Contribute to the development and maintenance of SAS programming infrastructure, processes, and data standards
• Lead programming activities for assigned projects and studies (e.g. leading submission), ensuring timely and high-quality deliverables
• Manage and oversee CROs and external vendors to ensure quality and compliance with expectations
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions
• Develop and implement data review, reporting tools, and statistical applications in partnership with cross-functional teams
• Review and validate SAS programs (SDTM, ADaM, and TFLs) generated internally or by CROs
• Review SAPs, DMPs, CRFs, annotated CRFs, TFL specifications, and other study documents, providing expert programming input
• Mentor and develop programmers, fostering a high-performing and collaborative team environment
• Provide hands-on support for complex analyses and ad hoc requests as needed
• Drive process improvements and efficiencies, including the adoption of automation and AI-based solutions in programming workflows

Senior Director, Statistical Programming

QA Engineer

• Assist QA Leadership with development and execution of planned QA audit schedules supporting GMP activities
• Partner with Technical Operations with selection and ultimate oversight of drug substance / drug product contract development manufacturing organizations (CDMOs) in support of Phase 3 and process performance qualification (PPQ) activities
• Independently performs assigned GMP audits
• Partner effectively with Technical Operations and provide quality guidance in GMP data and documentation generated
• Verify manufacturing and testing activities adhere to GMP regulations and guidelines and ensure a culture of continuous improvement
• Timely management of batch record review and release to ensure continuous supply for clinical trials, and to guarantee the consistent production of high-quality products
• Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards
• Provide QA support of device development activities (pre-filled syringes, autoinjectors, etc.)
• Maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and quality events
• Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures
• Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization
• Assist in establishing and reporting key quality metrics to monitor performance and drive improvements in GMP compliance and product quality
• Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness
• Ensure employees are adequately trained in GMP requirements and quality procedures
• Maintain comprehensive and accurate records and reports related to quality assurance activities
• Foster a culture of quality within the organization, emphasizing the importance of compliance, data integrity, and patient safety
• Assist in GMP inspection readiness activities to support regulatory authority inspections

Director, GMP Quality Assurance

Compliance

• Lead and coordinate interactions with project teams, clinical study teams, management, consultants, and collaborators to facilitate timely acceptance/approval of regulatory submissions including INDs, CTAs, NDAs, BLAs, and PIPs/PSPs, among others
• Support the data collection and cross-functional authorship for regulatory documents. Proofread, edit, and prepare documents for inclusion in regulatory submissions; coordinate with multiple departments to obtain content needed for submissions
• Communicate timelines for regulatory submissions to individuals and departments and follow up to ensure timely submission
• Serve as the primary interface with regulatory publishing to ensure compliant electronic submissions to FDA, and ex-US regulatory agencies as needed
• Appropriately archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system
• Implement and maintain use of standardized templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and advice to team members
• With mentoring and guidance from the regulatory affairs leadership team, understand and communicate US and international regulatory requirements to ensure quality documents are submitted either directly or in collaboration with a CRO or corporate partner
• Support global regulatory leads on clinical study and execution teams to ensure that clinical trial deliverables, timelines, and objectives are met

Senior Manager, Regulatory Affairs

Operations

• Plan, track, and manage logistics around biomarker sample collection across all our clinical trials, oversee sample shipments and testing at vendors, undertake sample reconciliation as needed, plan and inform teams on data delivery timelines, and manage final sample disposition.
• Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICFs, and lab manuals, and lead finalization of data transfer specifications.
• Maintain sample inventories, coordinate sample collection, and manage short-term and long-term sample storage solutions.
• Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance.
• Support and coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships.
• Support QA in vendor audit and inspection activities.
• Support activities related to biomarker budget planning and tracking of accruals.
• Lead vendor selection, performance management, and vendor oversight to ensure compliance with Apogee standards.
• Continuously identify and build best practices for process improvements.
• Ensure high quality data generation by overseeing sample integrity and external collaborations.

Senior Manager, Clinical Biomarker Operations

Manager

• Provide clinical system guidance as a Subject Matter Expert (SME) for clinical system operations and requirements across study team functions, CROs, and vendors.
• Lead and manage clinical system programs and projects end-to-end, including scope definition, planning, timeline management, resource coordination, and execution tracking.
• Manage and support clinical system (insourced and outsourced) related projects, with a focus on IRT, site portals, CTMS and eCOA, acting as a project/program manager.
• Establish and maintain project governance, including risk management, issue tracking, dependency management, and executive status reporting.
• Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner.
• Translate business and clinical requirements into technical specifications, ensuring alignment with IT, validation, and vendor teams for successful system implementation.
• Ensure compliance with clinical system SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles, applicable regulations, GCP requirements, and industry standards.
• Generate and report KPIs, metrics and analytics, identifying trends across the clinical systems portfolio, areas for improvement, and implementing changes as needed.
• Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required.
• Lead and support development and implementation of processes, procedures, supporting tools, and related training materials that adhere to regulatory requirements and industry best practices.
• Collaborate with Information Technology (IT), Quality Assurance, and Clinical System Validation teams to ensure effective system implementation, integration, and lifecycle management, including releases, updates, bug fixes, and enhancements.
• Oversee system integrations and data flows across platforms (e.g., CTMS, IRT, eCOA, eTMF, LMS), ensuring data integrity and interoperability.
• Create and provide clinical system training. Act as a primary support role for clinical system users and stakeholders.
• Execute change management activities to ensure consistent application of revised standards, processes, and systems functionality, including validation.

Senior Manager, Clinical Systems

• Head of GMP QA and member of the QA Leadership Team
• Build, lead, and scale a high‑performing GMP QA team
• Develop and execute the GMP QA functional strategy, ensuring alignment with company objectives and evolving clinical‑to‑commercial needs
• Establish a clear GMP QA vision that enables inspection readiness, scalability, and sustainable operations
• Provide oversight of GMP QA systems, including deviations, investigations, CAPAs, change control, complaints, and product disposition
• Ensure compliance with applicable global GMP regulations and standards (e.g., FDA, EMA, ICH)
• Lead organizational readiness for GMP internal audits and regulatory inspections
• Provide strategic oversight of GMP QA across CMOs, CDMOs, and external testing partners
• Ensure effective quality agreements, oversight models, escalation pathways, and performance metrics are in place and actively managed
• Exercise sound judgment in resolving quality issues with external partners in a timely and compliant manner
• Engage effectively with leadership and key cross‑functional partners, bringing forward clear recommendations and risk‑based perspectives
• Lead the development and presentation of Quality Management Review meetings for GMP QA to highlight compliance needs and to foster continuous improvement initiatives to support speed, clarity, and scalability

Executive Director – GMP Quality Assurance

• Design, develop, and implement analytical methods for the testing and characterization of biologics programs including monoclonal antibodies and other biologics modalities. The work will include partnership with contracted partners and/or internal analytical capabilities.
• Design, manage and execute experiments to support developability screening, upstream/downstream process development, process transfer, formulation studies, product characterization and comparability studies.
• Develop and execute analytical strategies with other stakeholders in support of the product and analytical method lifecycle, ensuring compliance with safety, quality, and regulatory requirements.
• Demonstrate technical excellence in method development and analytical characterization/comparability of biologics; build strong partnerships and collaborations internally and externally.
• Collaborate with cross-functional teams, including process development and R&D, to support project goals and timelines.
• Analyze and interpret complex data sets, providing clear and actionable insights and recommendations.
• Prepare technical reports, presentations, and documentation to communicate findings and progress to stakeholders.
• Author and review analytical sections of IND, IMPD, BLA, and MAA submissions.
• Stay current with industry trends, advancements to continuously improve analytical capability, methodologies and practices.