Company Summary Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF) and is planning a Phase 2 clinical trial. For more information, please visit avalynpharma.com and follow us on LinkedIn.Position Summary The Director of Clinical Operations is a senior-level position responsible for overseeing and managing the clinical operations of assigned clinical trials or program of trials. This role plays a critical role in ensuring the successful planning, execution, and monitoring of Avalyn’s global clinical trials and studies. This position will report to the VP of Clinical Operations and can be remote-based anywhere in the United States. Key Responsibilities (at the study or program level): - Strategic Leadership: Develop and implement the operations plans and logistics for their assigned study or program of studies aligning with the organization's goals and objectives. Provide leadership and guidance to the clinical operations team, ensuring the successful execution of clinical programs. - Clinical Trial Management: Oversee the planning, initiation, execution, and completion of clinical trials in accordance with applicable regulations, guidelines, and standard operating procedures (SOPs). Coordinate with cross-functional teams, including outside vendors, medical affairs, regulatory affairs, data management, and biostatistics, to ensure seamless trial execution. - Resource Management: Indirectly manage external providers’ study or program level resources to support clinical operations. Directly manage internal resources who support the Director’s assigned studies or program level of studies. Monitor resource utilization and implement strategies to optimize efficiency and productivity. - Quality Assurance: Ensure compliance with relevant regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal Standard Operating Procedures (SOPs), and other related quality standards. Work directly with the Avalyn Quality Management function to develop and maintain quality management systems to monitor and improve the quality of clinical operations processes. - Strategic Partner/Vendor Management: Oversee the selection, evaluation, and management of external partners/vendors, such as contract research organizations (CROs), central laboratories, and other service providers. Establish strong relationships with partners/vendors and negotiate contracts to ensure cost-effectiveness and high-quality deliverables. - Risk Management: Identify and mitigate risks associated with clinical trials, including protocol deviations, adverse events, and data integrity issues. Implement risk management strategies and develop contingency plans to address potential challenges and ensure patient safety. - Sponsor Oversight and Clinical Trial Management: Develop and implement clinical trial monitoring standards and best practices for effective monitoring of investigational sites and the overall quality and integrity of each assigned clinical trial or program of trials, in accordance with industry standards and practices. - Team Development: Operate as “one team” through clear and transparent communications and appropriate team building strategies. Provide mentoring, coaching, and performance feedback to enhance individual and team capabilities. Foster a culture of collaboration, innovation, and continuous improvement. - Stakeholder Engagement: Collaborate with internal stakeholders, such as senior management, clinical development teams, Key External Experts, and regulatory affairs, to align clinical operations strategies with broader organizational objectives. Establish strong relationships with external stakeholders, including investigators, study sites, and regulatory authorities. - Data Management and Analysis: Working internally/externally with data operations experts to understand the data collection, analysis, and interpretation of clinical trial data. - Business Process Improvement: Contribute to the identification of business process improvement needs or opportunities, and lead or participate in strategic and continuous business improvement initiatives in study planning & set up, study conduct & close out, vendor and CRO selection and management, budget development & management, and other initiatives to support Avalyn clinical development needs. - Personnel Management: Provide direct or indirect line management of clinical operations staff contract or consultant staff on an as-needed basis. Mentor and coach CO and other functional department team members on clinical trial operations. If in a formal line management role, conduct appropriately timed performance reviews, calibration sessions, and feedback discussions. Perform competency assessments and suggest approaches to address identified developmental opportunities. - Collaborate with the VP, Clinical Operations and colleagues from other functional groups with responsibilities in the therapeutic program (Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Finance, and Program Management) to ensure alignment of resources and tasks management to meet Avalyn business needs and to achieve Avalyn corporate goals. Qualifications and Requirements: - Degree required with a degree in life sciences, medicine, pharmacy, or a related field preferred. A Ph.D., M.D., or equivalent is appreciated but not required. - Extensive experience (typically 10+ years) in clinical operations within the healthcare or pharmaceutical industry, including significant experience in clinical trial management. - Experience in rare diseases and respiratory diseases/research highly preferred. - Strong working knowledge of applicable regulatory guidelines and requirements (e.g., FDA, EMA), as well as ICH-GCP and other relevant industry standards. - Proven leadership and management skills, with the ability to lead and motivate cross-functional teams. - Excellent organizational, planning, and project management abilities, with the capacity to handle multiple priorities and meet tight deadlines or successfully negotiate modifications. - Strong problem-solving and decision-making skills, with a focus on driving inspection readiness, continuous improvement, and operational excellence. - Demonstrated successful experience managing/overseeing Contract Research Organizations (CROs), vendors and other 3rd party suppliers - Experience working across all phases of clinical development (Phases I – III; phase IV experience helpful) - Working medical and scientific knowledge; experience in the Respiratory Therapeutic Area strongly desirable - Prior experience as Clinical Research Associate (CRA/monitor), Lead CRA, or Project Manager at either Sponsor, CRO helpful but not required - Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels. - Experience in vendor management and contract negotiation is desirable. - Familiarity with clinical trial technology and data management systems is an advantage. Business Requirements: - Limited business travel domestically and internationally may be required. - Fully remote position. - Ability to communicate in English (written and verbal). Fluency to read or speak other languages is beneficial. Proposed pay range $215,000—$230,000 USD

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Clinical Quality Lead is responsible for driving towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing, by providing GCP oversight for an argenx asset (applicable based on assignment), acting as GCP SME, supporting audit and inspection planning and execution, and manage clinical quality event investigations and remediation. The Clinical Quality Lead will also oversee relationship and performance of clinical partners vendors/suppliers, and act as GCP Quality Point of Contact (POC) for assigned Business Partners. ROLES AND RESPONSIBILITIES - Serve as the primary Quality point of contact for assigned clinical trials - Guide the Clinical Trial Team (CTT) to ensure clinical trials are conducted in compliance with GCPs, regulatory requirements, and argenx processes - Lead the GCP quality oversight for assigned clinical trials, collaborating closely with CTT(s) to uphold high-quality standards - Manage the clinical trial audit programs, including leading the audit site selection process for study-specific audit plans in collaboration with CTT(s), and ensuring timely audit conduct, reporting, review, and closeout in accordance with argenx processes - Oversee or lead the qualification/re-qualification of vendors as necessary - Participate in and lead audits to maintain compliance and quality - Work with CTT(s) to produce GCP quality system metrics for real-time quality monitoring and reporting (e.g., audits, deviations, CAPAs), and conduct trend analysis for management reporting - Drive the investigation of trial quality events and define necessary corrective and preventive measures - Lead clinical trial inspection readiness activities to ensure preparedness - Provide QA input during the creation/revision of argenx clinical procedural documents for GCP compliance - When assigned as “QA Approver” in ARGO or PhoeniQS, act as QA approver for GCP area. - Act as a delegate for R&D Quality head for the Document Review Committee (DRC) - Participate/lead in regulatory inspections - Oversee the relationship and performance of clinical partners/vendors to maintain quality standards - Support and own key GCP Quality processes per assignment and offer solutions/improvement from a continuous improvement mindset - Provide metrics and trends for continuous improvement, sharing lessons learned and best practices among other CTT(s). - Ability to mentor junior quality leads upon delegation by the R&D quality head. SKILLS AND COMPETENCIES - In‐depth knowledge of Clinical Trial related US and EU regulations and ICH GCP Guidelines - Preferred: Knowledge of global pharmacovigilance regulations - Ability to create a comprehensive study quality oversight plan and audit program and lead the execution - Proven capability to establish and maintain effective relationships with both internal and external stakeholders - Demonstrated ability to thrive in a dynamic environment within a rapidly growing biotech company, effectively managing challenging timelines. - Ability to influence without direct leadership: motivate and educate the clinical study team on clinical quality aspects EDUCATION, EXPERIENCE AND QUALIFICATIONS - MS Degree - Minimum 7 years clinical trial experience - Minimum 5 years quality assurance experience - FDA, EMA, MHRA, PDMA Inspection experience LI-Onsite ‎ For applicants in the United States: The annual base salary hiring range for this position is $152,000.00 - $209,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks. This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. • Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution. • Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting. • Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct. • Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Job description: Elevate Infusion Nursing Services is seeking a Contract RN Infusion Nurse to provide exceptional care for infusion patients. The ideal candidate will possess strong clinical skills, a passion for patient care, and the ability to work independently while maintaining high standards of safety and quality. As an Infusion Nurse, you will deliver specialized medications and educate patients in the home setting. You will play a vital role in ensuring safe, effective, and compassionate care tailored to each patient’s needs. Elevate Infusion Perks: - Flexible Schedule - Competitive Wages - Paid Drive Time - Independent Contractor Role - Great Company Culture The Infusion Nurse provides primary patient care for specifically assigned patients to include assessment, care planning, evaluation and education of patients receiving infusion therapy and/or nursing services in accordance with the care matrices and best practices in the home setting. Key Responsibilities include: - Ensuring the safe and effective delivery of these specialized medications. - Evaluate and educate patients and caregivers on administering infusion therapy safely. - Develop in conjunction with other team members the plan of care and evaluate response to therapy with each encounter. - Maintain scheduling and case management through the company's approved platform. - Communicate any scheduling changes on an as needed basis to appropriate team members. - Proficiently start peripheral intravenous line (PIV) and administer medications, such as IVIG or Biologics, in the home setting. - Submit thorough documentation within 24-48hrs of patient encounters. Requirements Qualifications: - Active and unrestricted RN license in the state of Missouri. - At least 2 years as RN with 1+ year in ER, ICU, or Infusion - At least 1 year of infusion or IV therapy experience (preferred). - Ability to independently start PIV lines and manage infusion therapy. - Strong organizational and communication skills. - Compassionate, patient-focused, and detail-oriented approach to care. Benefits Why Elevate Infusion? Most of our nurses already have a full-time job — and that's perfectly fine. Elevate Infusion is built for RNs who want to earn meaningful extra income on their own schedule, without the burnout that comes with it. What makes this different: - $48/hour for patient visit time and $35/hour for drive time — straightforward, competitive pay with no games - Truly flexible scheduling — you pick up visits that fit around your life, not the other way around - One patient at a time — no juggling 6 patients at once, no call lights going off down the hall, no chaos. Just you and your patient doing real clinical work - Work as much or as little as you want — whether that's a few visits a week or a full supplemental caseload, you control it - 1099 independent contractor status — you're running your own schedule like a professional - A chance to use your full skill set — IVIG and biologic infusions are high-acuity, clinically rewarding work that keeps your skills sharp The bottom line: Home infusion nursing is one of the best-kept secrets in the profession. The pay is better, the autonomy is real, and you'll finish a visit actually feeling good about the care you gave. If you've been looking for a way to earn more without burning out more, this is it.