Secura Bio, Inc.

• Collaboratively develop and implement global regulatory strategies across clinical development and commercial programs, including preparation and management of submissions • Act as primary liaison with regulatory agencies managing communications, meetings, inspections and responses to inquiries • Oversee preparation and submission of regulatory documents • Together with outside regulatory subject matter experts (consultants), provide strategic regulatory guidance to cross-functional teams including Clinical, CMC, Medical Affairs, Commercial, and others to align regulatory support with business goals • Provide strategic input to leadership on regulatory risk and risk mitigations • Stay current with evolving global regulatory requirements and trends, and communicate regulatory requirements, guidelines, and policy changes to internal stakeholders • Collaborate with Quality Assurance to ensure alignment between regulatory requirements, quality systems, and inspection readiness • Represent regulatory interests in product development governance committees and decision-making processes

• Lead day-to-day Quality operations, overseeing GxP activities to support commercial manufacturing and ongoing clinical trials, including compliance support and issue management • Own and manage the Quality Management System (QMS), ensuring compliance with global regulatory standards and alignment with corporate goals • Develop and oversee CAPA plans in response to Quality events, audits, and inspections; monitor CAPA effectiveness and closure • Manage quality oversight of CMOs, CROs, and other vendors; coordinate external audits and ensure effective supplier qualification and monitoring • Implement and maintain quality metrics, systems, and documentation associated with commercial product supply and clinical trials, including procedures, processes, tests, equipment, materials, regulatory requirements, and staffing proficiency • Provide leadership and strategic direction across Quality functions including Quality Systems, QA Operations, Supplier Quality, and Clinical Quality • Partner with Regulatory Affairs, CMC, Clinical, Supply Chain, and other cross-functional teams to ensure end-to-end GxP compliance • Drive continuous improvement initiatives to optimize quality processes, risk management, and inspection readiness • Serve as the point person for inspection readiness and regulatory agency inspections related to quality systems

• Set the national vision, strategy, and operating model for the U.S. MSL organization, aligned to medical and corporate priorities. • Lead, coach, and develop a geographically dispersed team of MSLs; recruit, onboard, and retain top scientific talent. • Define and govern standards for scientific engagement, including KOL strategy, external engagement planning, documentation, and compliant scientific exchange. • Oversee relationship-building with national, regional, and local KOLs, academic centers, and community networks to ensure consistent, high-quality scientific dialogue. • Partner with Medical Affairs leadership to develop and execute the integrated medical plan; ensure field priorities translate into clear territory plans and deliverables. • Establish mechanisms to capture, synthesize, and communicate field insights to inform cross-functional decision-making, evidence generation, and strategy refinement. • Serve as a senior scientific resource for major initiatives including congress strategy and execution, advisory boards, internal training, and strategic planning forums. • Collaborate cross-functionally with Clinical Development, Regulatory, Commercial, and Market Access to support clinical trial awareness, launch readiness, and post-launch evidence plans. • Ensure the MSL act as Key Contact Persons in the management of investigator-sponsored research proposals, ensuring timely review, communication, and alignment with corporate research priorities. • Own MSL performance measurement and impact reporting (KPIs/OKRs), including quality metrics, insight value, scientific engagement outcomes, and continuous improvement plans. • Oversee MSL tools and processes (e.g., CRM/activity tracking), field communications, and training to drive consistency, efficiency, and audit readiness. • Manage the national MSL budget and resourcing plans (headcount, territories, congress coverage) in partnership with Medical Affairs operations.

• Lead the development and execution of Medical Affairs aligned HEOR and real-world evidence (RWE) data generation for hematologic oncology assets across prelaunch and postlaunch phases. • Lead and identify evidence gaps relevant to clinical practice, treatment pathways, and patient outcomes in hematologic malignancies (e.g., lymphoma, leukemia, multiple myeloma). • Provide strategic input into Medical Affairs plans, including integrated evidence generation and scientific communication strategies. • Design and oversee observational studies, registries, chart reviews, and other RWE initiatives relevant to hematologic oncology populations. • Partner with Clinical and Biostatistics teams to ensure alignment between clinical trial data and RWE generation. • Oversee the development and interpretation of health economic analyses (e.g., cost effectiveness, burden of illness, healthcare resource utilization) to contextualize clinical benefit in hematologic oncology. • Ensure economic and outcomes evidence is scientifically rigorous, clinically meaningful, and suitable for external scientific exchange under Medical Affairs standards. • Collaborate cross functionally to ensure consistency of value messaging while maintaining Medical Affairs independence and compliance. • Lead or support the development of HEOR related abstracts, posters, manuscripts, and congress submissions in hematologic oncology. • Serve as a Medical Affairs HEOR subject matter expert to support MSL training, scientific platforms, and field medical needs. • Support compliant scientific exchange with external experts, cooperative groups, and other stakeholders on outcomes and RWE. • Work closely with Medical Directors, Clinical Development, Market Access, and Regulatory colleagues to ensure integrated and nonpromotional evidence planning. • Manage external vendors and academic collaborators to ensure high quality execution of HEOR studies. • Oversee timelines, deliverables, and budgets for assigned HEOR initiatives.