Senior Director, Real World Evidence Scientist

Role Summary

Senior Director, Real World Evidence (RWE) Scientist will serve as the product/indication RWE Lead, collaborating with internal and external stakeholders to develop and execute the RWE strategy in support of argenx marketed products or those in development. The role involves planning, designing, executing, and communicating findings from sponsor-initiated or partnered RWE programs to inform development, commercialization, and external communications with regulators, payers, HTA authorities, HCPs, and patient organizations. The role includes leading or supporting retrospective and prospective RWE projects, overseeing budgets, timelines, and quality, and reporting to the Head of Real World Evidence.

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 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

• 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

• Advanced degree in related discipline is required.

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.
• Travel: Ability to travel domestically and internationally up to 20% of time as needed.
• Job location: United States or Europe (remote acceptable).