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 use of Real-World Evidence (RWE) to support decision making by regulators, payors & health technology assessment (HTA) authorities, health care providers (HCPs), patient organizations, and other stakeholders has accelerated. In support of argenx marketed products or those in development, the Senior Director, Real World Evidence (RWE) Scientist, will serve as the product/indication RWE Lead, collaborating with internal and external stakeholders and decision makers to develop and execute the RWE strategy. He/she will plan, design, execute and communicate findings from sponsor-initiated or partnered RWE programs. This work may be used to inform internal development and commercialization efforts and to support communication with external healthcare decision makers and other stakeholders globally. For example, RWE objectives may include but not be limited to quantifying the burden of illness and the value of argenx’s innovative therapies to address that burden, identifying patient sub-groups of interest, providing data to inform clinical trial designs, supporting development and validation of Clinical Outcome Assessment and/or Patient Reported Outcomes measures, and generating data to address unanswered questions about our products/indications.
As the product/indication RWE lead, he/she will work closely with cross-functional argenx teams, including colleagues from HEOR, Clinical Development, Medical Affairs, Market Access, Commercial, Patient Advocacy, Business Development, Legal, Global Patient Safety, and Regulatory to align on the strategy and tactics for evidence generation. This individual will have broad responsibility to lead or support scientifically credible retrospective and prospective RWE projects as well as responsibility for oversight of relevant budgets, timelines, and quality. The Senior Director, Real World Evidence Scientist will report to the Head of Real World Evidence in the Medical Affairs & Evidence Generation organization.
ROLES AND RESPONSIBILITIES
Develop effective and efficient global RWE generation strategies for assigned molecules and their indications, co-creating them with cross-functional teams, with objectives of demonstrating unmet patient need and the value of argenx treatments throughout their lifecycle.
Design and lead robust and innovative RWE studies with input from internal and external stakeholders, from concept through execution and communication, that support internal development and commercialization needs, as well as to meet the evidentiary requirements of regulators, HTAs & payers, HCPs and the medical community, and patients.
Effectively execute projects within scope, budget, and timelines to assure the evidence generated can support ultimate objectives.
Deliver optimum impact of RWE through high-quality presentation at scientific congresses, publication in peer reviewed publications, use in proactive/reactive communication tools as well as inclusion in interaction with regulators, HTAs/payers, HCPs/medical community and patient organizations.
Develop and deliver RWE presentations, serving as an argenx ambassador engaging with external stakeholders such as patient organizations and HCPs.
Conduct internal training on RWE to inform argenx colleagues of the importance and potential value of this evidence as well as the challenges of these projects.
SKILLS AND COMPETENCIES
Teamwork: Understands the value of co-creation in a matrixed environment with diverse stakeholders and across multiple geographies. Achieves superior results by redefining problems through collaboration with others and obtaining expert internal or external advice. Contributes to building a positive team dynamic to foster enterprise success.
Creativity & Innovation: Considers evolving nature of data and evidence generation. Seeks opportunities to identify and utilize novel data generation approaches that can accelerate data collection and/or is patient-centric to address unmet research needs.
Problem solving and adaptability: Adopts an open approach to understand opportunities and creates solutions that address requirements or constraints constructively. Is able to adapt to and manage competing demands and changing circumstances to best meet evolving needs.
Technical excellence: Has a thorough understanding of RWD collection and RWE generation (including different types of RWE studies), applicable regulatory and methodologic guidances, and can manage research projects to successful delivery.
Leadership: Has humble confidence to influence and lead others to address complex challenges. Can effectively bring about change to deliver results through others. Values empowerment of others.
Communication: Speaks and writes clearly and persuasively. Is able to translate and communicate rationale for and aspects of RWE to internal and external collaborators and stakeholders.
EDUCATION, EXPERIENCE AND QUALIFICATIONS
Minimum 10 years’ experience in pharmaceutical/biotech industry or in consulting serving that industry with strong knowledge of pharmaceutical development and commercialization, scientific project management (including budgeting and contracting), cross-functional team management, KOL/external stakeholder & partner management, and compliance and regulatory requirements is required.
Minimum 5 years’ experience and broad understanding of using RWE for maximum internal and external impact, including retrospective and prospective RWE expertise, project design and execution from feasibility analysis and need determination to full RWE study development, set up, governance, and study execution and communication is required.
Advanced degree in related discipline is required.
Experience working in rare diseases is preferred.
Ability to travel domestically and internationally up to 20% of time as needed.
Job location: United States or Europe (remote acceptable)
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.
