Apogee Therapeutics

Supply Chain

• Review clinical trial synopsis and/or protocols to understand IMP supply and demand requirements.
• Assist in packaging and supply strategy development using Excel or SaaS based forecasting tools to maximize efficiency and minimize waste while maintaining a low risk profile.
• Coordinate with third-party vendors including packaging suppliers, distribution centers, freight forwarders, and courier services.
• Support domestic and international logistics for clinical studies by ensuring timely and compliant delivery across the supply network, monitoring shipment visibility, and helping resolve logistics deviations including delays, temperature excursions, and customs issues.
• Support the Demand & Operations Planning (D&OP) process across assigned studies in collaboration with Supply Chain Operations.
• Monitor and report inventory levels at depots and clinical sites through the life of a trial; alert supply lead to avoid potential supply issues.
• Assist in developing requests for proposals for packaging, labeling, storage, and distribution.
• Review vendor invoices and provide input for accruals and budget tracking as applicable.
• Support vendor performance monitoring and governance reporting.
• Ensure supply chain activities adhere to GMP, GDP, and applicable regulatory guidelines (FDA, EMA, ICH).
• Contribute to the development and maintenance of SOPs and work instructions to support operational excellence.
• Support regulatory inspections and audits through thorough documentation and record-keeping.
• Participate in cross-functional project teams and contribute to continuous improvement initiatives.

Senior Specialist, Supply Chain Management

Director

• Apply deep expertise in biology and pharmacology to provide strategic scientific vision and guide therapeutic I&I biology research across atopic dermatitis, allergic asthma, EoE, and other I&I indications.
• Design, develop, and oversee disease-relevant and complex in vitro and ex vivo models using multiple primary human cell types to evaluate the mechanism of action of Apogee antibodies and target biology.
• Contribute to authoring and reviewing regulatory submissions and publications.
• Manage and coordinate projects (in-house & CRO) to ensure adherence to timelines and goals.
• Establish and promote laboratory best practices.
• Analyze and interpret complex data from studies to inform on program decisions and effectively communicate outcomes and recommendations to the research group and senior leaders.
• Collaborate with scientists across functions to generate high-quality data supporting programs from discovery through development.

Associate Director, Inflammation Biology

Medical Director

• Identify emerging safety signals and ensure appropriate escalation through internal safety governance pathways.
• Contribute to the development and execution of pharmacovigilance strategies for Apogee clinical programs across various stages of development.
• Maintain ongoing benefit–risk assessments incorporating disease severity, unmet medical need, and emerging clinical data.
• Collaborate with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.
• Ensure high-quality MedDRA coding, appropriate event characterization, and robust safety narratives.
• Lead preparation and review of DSURs, Investigator’s Brochures (IBs), safety sections of protocols, informed consent forms (ICFs), and clinical study reports.
• Provide safety input to regulatory submissions (INDs/CTAs), protocol amendments, and responses to health authority inquiries.
• Partner with Regulatory Affairs and Quality teams to address safety findings, deviations, and corrective and preventive actions (CAPAs).
• Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, and Medical Writing.
• Support the development of the Integrated Summary of Safety (ISS), and the safety-related components of the New Drug Applications (NDA)/Biologics License Application (BLA), and Marketing Authorization Applications (MAA), in compliance with global regulatory standards.
• Review safety content of scientific publications such as posters, abstracts, and manuscripts.

Medical Director – Pharmacovigilance

• Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan
• Support the design of trials and develop protocols and other relevant documents for individual studies
• Support start-up activities related to assigned studies
• Oversee day-to-day clinical and medical execution of studies
• Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
• Partner with clinical operations on site selection, recruitment, and CRO management
• Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards
• Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable

Medical Director – Dermatology

• Lead the development of biomarker strategies and execution for clinical development of programs in inflammatory and immune indications.
• Work across functions in Translational Research and Clinical Biomarkers to design, prioritize and execute biomarker strategies for clinical programs in I&I indications.
• Distil and communicate biomarker plans, rationale, concepts and findings to internal stakeholders at appropriate levels for different audiences.
• Execute in a highly matrixed model where strong communication and partnership skills are critical to success.
• Work closely with clinical operations, biomarker operations, medical and clinical development leads in driving the program to the clinic including finalization of lab manuals by providing input to specimen handling, collection, shipping and storage guidelines.
• Set up sample testing timelines and oversee data transfers.
• Lead the development and implementation of assays using flow cytometry, immunoassays, proteomics, and genomics-based tools for inclusion in clinical trials.
• Partner closely with Biomarker Operations and Biomarker Laboratory members to drive optimization and execution of assays.
• Collaborate with Research, Biomarker Lab team and Biomarker Operations to assess method feasibility and supervise assay transfer to CROs.
• Design and oversee experiments to troubleshoot assay performance issues.
• Establish relations with CROs, or academic laboratories, to execute biomarker strategy, monitor assay development including qualification/validation and biomarker testing in clinical trials to ensure high quality biomarker data.
• Analyze and interpret biomarker data generated across multiple platforms, in conjunction with biostats and computational biologists, to provide guidance on program impact and next steps.
• Contribute to biomarker sections of all regulatory documents; including INDs and BLAs, clinical protocols, clinical study reports, and other study related documents.
• Author and present biomarker data to internal and external scientific community, including press releases, posters and publications, to articulate the “why” and the “so what” behind the biomarker deliverables.

Associate Director, Biomarker Development

• Monitor clinical trial conduct for quality, safety, protocol compliance, and data integrity
• Perform ongoing review and interpretation of emerging clinical trial data, including safety, efficacy, and operational trends
• Collaborate cross-functionally to develop and review key clinical documents including protocols, informed consent forms, investigator brochures, clinical study reports, medical monitoring plans, safety narratives, and scientific presentations
• Collaborate with Data Management and Biostatistics to support data review, data cleaning activities, database locks, and validation of data collection tools
• Partner closely with Clinical Operations and CRO partners to support site management, enrollment and retention strategy, issue escalation, and study execution
• Develop strong working relationships with investigators, study coordinators, and key external stakeholders
• Stay current on scientific and clinical developments in atopic dermatitis and immunology to support competitive awareness and strategic planning
• Support inspection readiness activities and ensure compliance with GCP and applicable regulatory requirements

Associate Director, Clinical Development – Immunology

• Technical lead on cross-functional teams responsible for development of combination products
• Work with Quality function to develop and refine the combination product quality management system
• Author product-specific Product Realization documentation, including User Requirements Specifications, Design and Development Inputs, and Design and Development Verification plans, protocols, and reports
• Oversee test method development, test method validation and design verification at external labs
• Establish human factors strategies and work with human factors service vendors to execute formative and summative HF studies for Design and Development Validation
• Work with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to meet development, manufacturing, and supply goals
• Review and approve manufacturing protocols, master and executed batch records, validation plans and reports, and other cGMP documents
• Support person-in-plant during manufacturing at CMOs, as needed
• Serve as technical SME in root cause analysis and deviation investigations
• Author, review, and approve development studies and technical reports
• Collaborate effectively with cross-functional teams, including analytical development, supply chain, quality assurance, and regulatory affairs
• Serve as technical SME on due diligence and business development opportunities
• Communicate findings and progress through presentations and reports
• Author and support regulatory submissions (IND, IMPD, amendments, BLA, etc.)

Associate Director – Device Development

Compliance

• Serve as the dedicated IT business partner for the Quality organization; develop a deep understanding of QA processes, priorities, and roadmap to anticipate and address IT needs proactively
• Own Veeva Vault Quality (QualityDocs and associated modules) as the IT system owner: manage system configuration, user administration, release management, and enhancement delivery in partnership with QA stakeholders
• Translate Quality business requirements into system enhancements, workflow changes, and configuration updates; manage the enhancement backlog and release cycle in coordination with QA and vendors
• Advise Quality on system risk, compliant use of technology, and IT implications of process changes; serve as a trusted technical advisor on how systems can best support quality operations
• Participate in QA planning meetings and strategic initiatives to ensure IT capabilities and constraints are represented from the outset
• Author validation scripts, test protocols, and supporting documentation (IQ/OQ/PQ) for GxP-regulated systems including Veeva Vault, SAS Validated Cloud, Egnyte GxP, and validated MuleSoft integrations; partner with QA for CSV review and approval
• Assess system changes for validation impact; manage change control documentation and ensure validated systems are maintained in a compliant state following changes
• Conduct and document periodic reviews of validated systems; manage decommissioning procedures in line with regulatory requirements
• Own IT inspection readiness across the validated systems portfolio.
• Partner with QA to ensure IT systems and electronic records meet 21 CFR Part 11 and other regulatory requirements; lead IT response to inspection findings and drive remediation to closure
• Maintain audit-ready evidence packages for GxP systems: audit trail integrity, access control records, system configuration documentation, and change history
• Own the IT policy library: author, version, and maintain SOPs and policies covering electronic records, audit trails, access control, change management, data classification, and AI use
• Develop and deliver IT compliance training; maintain training records in validated learning management infrastructure
• Manage the IT third-party risk management program: vendor tiering, GxP qualification assessments, data handling reviews, and ongoing oversight for technology suppliers and SaaS providers.
• Evaluate new technology and AI vendors against Apogee’s governance framework prior to onboarding; coordinate security assessment inputs with the Director of Cybersecurity

Director, IT Quality – Compliance

Artificial Intelligence

• Own end-to-end execution of the AI Enablement Program: working group facilitation, use case pipeline management, adoption tracking, and executive reporting
• Drive AI literacy and responsible use across a diverse workforce, meeting employees where they are and building capability without coercion
• Design and deliver training and engagement programs calibrated to varied audience profiles and functional contexts
• Manage the use case intake pathway from submission through scoring, cross-functional review, and outcome documentation
• Coordinate with external AI strategy and implementation partners to maintain an integrated, non-duplicative delivery pipeline
• Partner with Cybersecurity on AI tool security reviews, access control requirements, audit logging, and risk response protocols
• Collaborate with Legal and Compliance on data privacy, IP risk, MNPI controls, and contractual obligations across AI deployments
• Work with Data Engineering & Analytics to align AI tools with the enterprise data platform and govern data access across regulated and non-regulated environments
• Engage Clinical Operations, Regulatory Affairs, and Medical teams to surface, prioritize, and advance AI use cases in trial and submission workflows
• Partner with Finance, HR, Commercial, and G&A leadership on non-clinical use case discovery and deployment
• Facilitate the AI Working Group, maintaining cross-functional accountability and structured deliberation on tool assessments and program priorities
• Serve as the enterprise administer on the AI and agent tool landscape, owning tool selection, lifecycle management, and the capability roadmap across LLM platforms, agentic workflows, productivity tools, and clinical AI applications
• Evaluate net-new tools and agentic frameworks through the governance assessment pathway before deployment; maintain the approved tool inventory with current risk classifications
• Manage vendor relationships, contract terms, and licensing decisions in coordination with Finance, Legal, and Procurement
• Stay ahead of capability shifts in the agent ecosystem and proactively surface opportunities.
• Administer the AI Governance Framework: Approved Systems Registry, risk classification tiers, and GxP and non-GxP assessment pathways
• Ensure AI deployments meet applicable regulatory, privacy, and data integrity standards, and support audit readiness across GxP-adjacent environments
• Evolve governance controls as the tool landscape and regulatory environment change.
• Define and own program success metrics, such as adoption rates, use case throughput, time-to-assessment, literacy baselines, and quantified efficiency gains by function
• Establish a reporting cadence to leadership and the Governance Committee with clear narrative on program ROI and risk posture
• Maintain a use case outcomes repository to capture lessons learned and identify replication opportunities across the organization
• Benchmark Apogee’s AI maturity against clinical-stage biotech peers and industry best practice to prioritize program investments

Director, AI Enablement

• Participate in the design and execution of clinical studies in a new therapeutic area (Gastroenterology)
• Contribute clinical and strategic perspective to EoE development program through BLA
• Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution, including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan
• Contribute to the design of trials, and develop protocols and other relevant documents for individual studies
• Lead study start-up activities
• Direct day-to-day clinical and medical execution of studies
• Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
• Partner with clinical operations on site selection, recruitment, and CRO management
• Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards and Investigator Meetings
• Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable

Senior Medical Director, EoE

• Develop and execute global Medical Affairs strategy for EoE
• Serve as a senior, strategic, thought partner across multiple teams and forums within Apogee
• Establish global KOL relationships and build scientific leadership in the field
• Support clinical development, site identification, and evidence generation
• Collaborate cross-functionally across multiple teams
• Ensure compliance with all regulatory standards

Executive Director, Medical Affairs – Eosinophilic Esophagitis

• Collaborate with cross-functional teams to develop clinical documents for trials with scientific rigor, such as protocol, investigator brochure, clinical study report, scientific publications/presentations, etc.
• Contribute scientific input and implementation into the study design and execution, including but not limited to selection of appropriate endpoints, patient populations, and study methodologies; site selection; investigator meetings; and study initiation activities
• Monitor the clinical trials for both quality and safety, ensuring adherence to protocols, timelines, and quality standards
• Analyze clinical trial data, interpret results, and provide scientific insights to guide decision-making
• Collaborate with data management and biostatistics to develop and validate data collection tools and ensure accurate and timely data capture
• Foster relationships with clinical investigators to gather insights, address scientific questions, and promote collaboration
• Stay current with scientific literature and advancements in immunology related to Apogee’s pipeline
• Collaborate with clinical operations, medical affairs, regulatory affairs, biostatistics, and other teams to ensure alignment of clinical strategies with overall program goals

Director, Clinical Development – Clinical Science

• Conduct market research on distribution strategies and trends within Immunology and Atopic Derm to understand the current distribution landscape and network
• Define and lead Apogee’s enterprise channel strategy across wholesale, specialty distribution, and specialty pharmacy networks as we advance our pipeline into commercialization
• Design optimal distribution models (e.g., open vs. limited networks, specialty pharmacy, hub integration) aligned with product strategy, patient journey, and access goals
• As we approach launch, design and implement a high-performing specialty pharmacy network, including selection criteria, network size, and performance management framework
• Lead the negotiation, contracting, and ongoing management of wholesalers, specialty distributors, and specialty pharmacies
• Ensure network readiness for product launch, including data integration, reporting, inventory, and patient onboarding workflows
• Build and maintain senior-level relationships with key trade and distribution stakeholders to position Apogee as a partner of choice
• Continuously assess and optimize network performance to improve speed to therapy, patient experience, and adherence
• Conduct a patient services landscape assessment across Atopic Derm brands, other Dermatology brands to benchmark the scope of offerings and programs in the current market to guide in shaping Apogee’s patient services
• Build and lead a comprehensive patient support program, including hub services, benefits investigation, prior authorization support, co-pay assistance, patient education, and adherence programs
• Build and lead a team of Formulary Reimbursement Managers that will build relationships and provide industry-leading support to HCPs on reimbursement dynamics and challenges
• Ensure a seamless, patient-centric experience from prescription through therapy initiation and persistence
• Select, onboard, and manage vendors supporting patient services and hub operations
• Define and track KPIs (e.g., time to therapy, abandonment rates, adherence) and drive continuous improvement
• Partner cross-functionally with Market Access, Commercial Strategy, Supply Chain, Medical, Regulatory, and Legal to ensure aligned and compliant execution
• Provide input into forecasting, financial modeling, and scenario planning related to distribution and patient services
• Build, lead, and develop a high-performing team across channel strategy, trade relations, and patient support
• Coach and develop talent, establishing capabilities needed for future growth and launches

Senior Director, Channel Strategy and Patient Support

Content Writer

• Collaborates with cross-functional teams to prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to: protocols, investigator’s brochures, clinical study reports, briefing documents, Module 2 summary documents, and other clinical and regulatory documents.
• Communicates deliverables needed, writing process, and timelines to team members, and holds team members accountable to agreed-upon document milestones.
• Negotiates with functional areas regarding deliverables and timelines to meet conflicting demands, removing barriers and using creativity to ensure teams achieve document-related project goals
• Ensures compliance with relevant regulatory guidelines, industry best practices, and ethical standards in medical writing and communication.
• Maintains document templates, style guides, and best practices to ensure consistency and quality in written materials.
• Oversees the planning, coordination, and execution of medical writing projects by external vendors and consultants to ensure milestones are met and resources are allocated efficiently.
• Leverages AI-enabled tools to enhance efficiency and quality of medical writing deliverables while maintaining scientific rigor and regulatory compliance.
• Helps define and implement best practices for the responsible use of AI within medical writing workflows.
• Provides guidance to less experienced medical writers and external vendors.

Senior Manager, Medical Writing

• Data steward of regulatory data in the RIM system (e.g., enter, update, and maintain), ensuring accuracy, completeness, and timeliness
• Create, archive, and maintain regulatory submissions, Health Authority correspondence, and Health Authority commitments within the RIM system, in accordance with internal standards
• Maintain submission trackers, timelines, track submission history and Health Authority commitments to ensure visibility into milestones
• Coordinate with cross-functional teams and Regulatory Operations to support US submission planning, compilation, and timely delivery of regulatory documentation
• Support preparation and organization of regulatory submission components (e.g., INDs, CTAs, amendments)
• Perform QC activities (including eCTD QC for US submissions, as appropriate) to ensure completeness, consistency, and technical readiness
• Support inspection readiness activities (e.g., TMF health checks, document completeness reviews)
• Support department meetings and cross-functional communication, including agenda development, coordination of materials, and documentation of outcomes