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.
argenx is a global immunology company focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex targets to treat diseases with significant unmet medical need. It is an exciting time of growth for argenx as we strive to achieve our VISION 2030, our long-term commitment to transform the treatment of autoimmune diseases by strengthening our leadership in neonatal Fc receptor (FcRn) biology, investing in our continuous pipeline of differentiated antibody candidates, and scaling in a disciplined way to ensure innovation remains core to the argenx mission.
Changes in healthcare systems with advances in medicine and health technologies have accelerated the use of Real-World Evidence (RWE) to support decision making on adoption of our innovative therapies across multiple stakeholders. To prepare for successful product launches and market access, argenx requires timely evidence of burden and value for Healthcare Decision Makers. To better understand these patient populations and how treatments are used in real world settings, especially those with rare diseases, argenx requires evidence to understand the patient journey from diagnosis through treatment with available therapies.
argenx is committed to elucidating the burden of illness faced by patients and caregivers and their approach to treatment for the conditions we seek to address. This includes generating and communicating evidence to answer questions from healthcare decision makers including regulators, payors, HCPs, patient advocacy organizations, and other stakeholders to accelerate appropriate patient access to our innovative therapies and understand their utilization.
The Head, Real World Evidence (RWE), will collaborate with internal and external stakeholders and decision makers to develop the strategy for the use of RWE as well as the planning, design, and execution of RWE programs through sponsor-initiated and/or partnered efforts. This work may be used to support communication with healthcare decision makers and other stakeholders globally about the burden of illness and the value of argenx’s innovative therapies to address that burden, provide data to inform clinical trial designs, identify patient subgroups of interest, and support development and validation of Clinical Outcome Assessment and/or Patient Reported Outcomes, and generate data to address unanswered questions about our marketed products/indications.
The Head, Real World Evidence will lead a team of RWE Scientists and work closely with cross-functional argenx teams, including HEOR, Clinical Development, Medical Affairs, Market Access, Commercial, Patient Advocacy, Business Development, Legal, Global Patient Safety, and Regulatory to align on the strategy for evidence generation efforts with identified evidence gaps. This individual will have broad responsibility to support scientifically credible retrospective and prospective RWE projects that include working with external clinical and research experts, patient advocates, and other external partner companies. Additionally, the Head, RWE, will be responsible for the oversight of the team’s projects, budgets, timelines, and data dissemination.
Roles and Responsibilities:
Develop a cohesive RWE generation strategy for our molecules and their indications. Lead and maintain RWE generation plans co-created globally with Medical Affairs, HEOR, Clinical Development, Regulatory, Market Access, and Brand Marketing aligned with strategic plans for demonstrating unmet patient need and the value of argenx treatments throughout their lifecycle.
Working with the cross-functional stakeholders and aligned with the 3-5 year integrated global evidence generation plans, determine if a RWE study is the most appropriate approach to address the questions of interest.
Partner with argenx stakeholders broadly to identify, select, and execute prospective RWE projects and external partners for execution, with consideration for KOL and patient advocacy integration, regulatory concerns, and legal compliance.
Conduct feasibility assessments to determine the likely success of any RWE study.
With relevant team members lead RWE studies to develop protocols, including the development of project and governance plans, with consideration for the incorporation of KOL and patient advocates.
Manage day-to-day execution of studies and related projects which may include overseeing site recruitment and onboarding, monitoring data collection at the site level, loss to follow-up at the patient level, timeline management, conduct and timing of analyses, and budget management.
Oversee study conduct from a human subjects perspective ensuring appropriate IRB/EC approvals are secured and development of plans for informed consent appropriate for observational studies.
Lead broad evidence dissemination through high-quality publications in collaboration with investigators, HCPs, patient advocates, and partners as appropriate. This will also require collaboration with Scientific Communications in the development of integrated 3-5 year publication and congress plans for the dissemination of this data.
Upon request, and in partnership with field Market Access and Medical Affairs, develop and deliver RWE presentations to external stakeholders.
Work closely with HEOR and market access to utilize secondary data sets for retrospective data collection necessary to support payer and access needs.
Conduct internal training when relevant on RWE to inform argenx the importance and potential value of this evidence and the unique challenges in developing and running these projects.
Skills and Competencies:
Communication: Listens and seeks clarification. Responds well to questions. Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information. Able to communicate data to stakeholders with various levels of expertise in RWE.
Innovation: Thinks about the future state of data generation. Seeks opportunities to identify and utilize novel data generation approaches that can accelerate data collection and/or is patient-centric to address open questions. Able to assess emerging platforms and tools to collect real world data.
Teamwork: Understand the value of co-creation and ability to seek input from and understand the needs of multiple stakeholders and across multiple geographies. Balances team and individual responsibilities. Gives and welcomes feedback. Contributes to building a positive team spirit. Understands the value of the team’s success vs one’s own interests. Supports everyone's efforts to succeed. Contributes to building a positive team spirit. Shares expertise with others.
Team and people management: Able to coach and develop people. Values empowerment of others. Understands working in a matrixed environment.
Adaptability: Able to adapt. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with change, delays, or unexpected events.
Technical Mastery and Skills: Knowledge of and experience in different types of RWE studies, e.g. observational non-interventional studies, disease management, prospective cohort studies, etc. Knowledge of recent regulatory interest in RWE and how we might leverage RWE for regulatory purposes. Able to assess own strengths and development areas. Pursues training and opportunities for growth. Strives to continuously build knowledge and skills.
Priority setting: Effectively sets clear priorities among competing opportunities. Leverages experience and know-how to focus on priority objectives. Able to balance short-term and long-term goals.
Thinking / Problem solving: Adopts an open approach to understand opportunities and situations to create solutions by developing options that address stakeholder requirements or constraints in a constructive manner.
Education, Experience and Qualifications:
Advanced degree in Health Economics, Outcomes Research, Pharmacoeconomics, Epidemiology, Health Services Research or related discipline is required (PhD, MS, MPH).
Minimum 10 years consulting and/or working in pharmaceutical/biotech industry: knowledge of pharmaceutical development, scientific project management, RWD collection, RWE generation, and compliance and regulatory requirements.
Minimum 5 years prospective RWE study experience: In-depth understanding of project design and execution from feasibility analysis and need determination to full prospective RWE study development, set up, governance, KOL/external stakeholder/partner management, and study execution.
Experience in both prospective and retrospective real world evidence data generation preferred. Experience working in rare diseases is a plus.
Ability to travel up to 25% of time as needed (domestic and global) with the ability to spend some time in the Boston and Gent offices and attend relevant conferences.
Job location: US (remote okay)
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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.
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.