Apogee Therapeutics

Role Description We are seeking a Therapeutic Area (TA) Head, Respiratory - Clinical Development. In this newly created position, you will be primarily responsible for developing and executing an integrated clinical development strategy and clinical trial programs in respiratory. In this leadership role, you will have the opportunity to guide and mentor a team of experienced Medical Directors and Clinical Scientists. As part of a growing Clinical Development organization, you will be responsible for providing clinical expertise, obtaining scientific advisory input from external experts, working cross-functionally to develop clinical studies, leading clinical aspects of regulatory interactions for product advancement, and partnering with the clinical operations team to provide medical and strategic input to achieve operational excellence. The TA Head will have expertise in respiratory disease, have demonstrated effective collaborative skills to work across various phases of clinical development with an emphasis on later stages (phase 2 and beyond), and serve as a medical expert for multiple cross functional teams. Building relationships with Investigators is essential for this role including meeting with sites to foster collaboration and training. Apogee offers a dynamic, fast paced and highly collaborative approach to drug development. The Therapeutic Area Head will oversee programs across the respiratory portfolio. The position reports to the SVP, Head of Clinical Development. Key Responsibilities - Build, lead and mentor a team of Medical Directors and Clinical Scientists focused on Apogee’s respiratory portfolio, including monotherapy and combination therapies. - Apply expertise in the treatment and management of respiratory conditions to advance the strategy and clinical development of Apogee’s medicines for the benefit of our patients. - Work cross-functionally with Program Leadership/Management, Biometrics, Medical Affairs, Clinical Pharmacology, Regulatory Affairs, Research & Translational Medicine, Commercial and other functions to develop the overall clinical development strategy in respiratory indications. - Collaborate with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to execute and successfully complete clinical trials across development phases leading to BLA filings and approvals. - Help establish and maintain a network and relationships with respiratory experts, investigators and opinion leaders. - Contribute to the scientific communication strategy of Apogee Therapeutics via publications, manuscripts, abstracts, posters and scientific presentations. - Participate in medical review of adverse event reports and monitoring of incoming safety data in collaboration with pharmacovigilance, including evaluating and escalating safety signals. - Coordinate and develop information for reports submitted to FDA, EMA, PMDA and government, regulatory, or partner agencies. - Present to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and key opinion leaders. - Maintain knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review. - Review and edit clinical study reports. Qualifications - Board certified MD with expertise in respiratory and/or immunology drug development and experience across later stages of clinical development. - 10+ years' biotech or pharmaceutical industry experience in a leadership role building and mentoring clinical development teams (MDs and non-MDs). - Passion for bringing better treatment options to patients and caregivers. - Knowledge of clinical development strategies and trial execution for biologics and immunology therapeutics in the US and globally. - Self-starter who will bring expertise and inspiration to the team, is able to multi-task in support of clinical development programs and has a growth mindset. - Leads and works collaboratively with cross-functional teams in a fast-paced, hands-on and dynamic environment. - Strong leadership, communication and presentation skills. - Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless. - Position requires approximately 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, as well as team meetings, medical conferences, etc. Benefits - A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless. - Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. - Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. - We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave. - Commitment to growing you professionally and providing access to resources to further your development. - Apogee offers regular all team, in-person meetings to build relationships and problem solve.

• Provide strategic and operational leadership for DM systems (e.g., EDC, ePRO/eCOA, RTSM, CTMS integrations) • Lead selection, implementation, optimization, and governance of DM technologies and platforms to support scalable, high-quality data management across clinical development programs • Champion data standards (e.g., CDISC, SDTM) and metadata-driven approaches • Partner with Biostatistics, Programming, and IT to ensure seamless data flow and interoperability across systems • Evaluate emerging technologies (AI/ML, automation, decentralized trial tools) to enhance data quality and efficiency • Provide strategic leadership and oversight of DM activities across assigned clinical programs (Phases I–III and beyond) • Serve as the DM lead on cross-functional program teams, influencing study design, timelines, and data strategy • Ensure delivery of high-quality, submission-ready datasets in alignment with program milestones • Proactively identify risks to data quality, timelines, or deliverables and implement mitigation strategies • Oversee all DM deliverables including CRF design, database build, data cleaning, coding, and database lock • Establish and maintain data review strategies, including centralized monitoring and risk-based approaches • Ensure compliance with GCP, ICH guidelines, and regulatory requirements (FDA, EMA, etc.) • Drive inspection readiness and support regulatory submissions • Provide strategic oversight of CROs and external data vendors • Define scope, KPIs, and performance metrics; ensure accountability and high-quality deliverables • Build, mentor, and lead a high-performing DM team • Foster a culture of accountability, innovation, and continuous improvement • Provide coaching and career development for team members • Develop and standardize DM processes, SOPs, and best practices • Drive initiatives to improve efficiency, scalability, and data quality • Lead or contribute to cross-functional initiatives related to data strategy and digital transformation.

• Planning and executing medical congresses, including abstract and presentation development, booth design and build coordination, on-site logistics, and pre/post-congress communications to ensure a compelling and compliant scientific showcase. • Supporting development and execution of the scientific communications plan, including publications planning, field medical materials, manuscript and abstract coordination, and vendor management. • Owning the strategic scientific communication plan for one or more therapeutic areas or geographies. • Managing end-to-end Medical/Legal/Regulatory (MLR) review of medical communications materials, including routing, comment reconciliation, version control, approvals, and archival in the MLR system of record. • Collaborating with internal stakeholders across Medical Affairs, Clinical Development, Biostatistics and other functions to develop and disseminate scientific content that accurately reflects Apogee’s data. • Managing external agency and medical writing vendor relationships for key projects to ensure quality, compliance, and on-time delivery. • Contributing to additional scientific communications initiatives as the pipeline evolves and organizational needs shift.

• 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.

• 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.

• 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.

• 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

• 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

• 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.

• 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