Apogee Therapeutics

General

• Collaborate with clinical study teams to provide medical and scientific support to clinical trial sites
• Support site engagement, education, and execution of respiratory (asthma-focused) clinical studies
• Develop and maintain strong relationships with investigators, key opinion leaders, and external stakeholders, including pulmonologists and allergists/immunologists
• Serve as a credible scientific resource, providing timely, accurate, and relevant information on Apogee’s development programs
• Stay current on emerging data, publications, and clinical trends in asthma and respiratory disease to effectively engage external experts
• Maintain awareness of competitor products, biologics, and evolving treatment paradigms in asthma
• Partner cross-functionally with Medical Affairs, Clinical Development, Clinical Operations, and Business Development & Strategy to ensure alignment
• Gather and communicate actionable field insights to inform clinical strategy and development decisions

Medical Science Liaison – Respiratory

• Clinical Support
• Collaborate with the clinical study teams to provide medical and scientific support for clinical sites
• Key Opinion Leader (KOL) Engagement:
• Develop and maintain strong relationships with clinical study investigators, key opinion leaders, and other external stakeholders in the field of dermatology
• Act as a credible, scientific resource for KOLs, providing them with up-to-date and relevant information on Apogee’s development programs
• Stay abreast of the latest developments, publications, and research in dermatology to effectively communicate with experts in the field
• Stay informed of competitor products and market trends in dermatology
• Internal Collaboration
• Work closely with cross-functional teams, including Medical Affairs, Clinical Development, Clinical Operations, and Business Development & Strategy to ensure strategic alignment
• Provide insights and feedback to internal teams based on interactions with external stakeholders

Medical Science Liaison – Dermatology

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