Associate Director - Real World Evidence
Changes in healthcare systems with advances in medicine and health technologies have accelerated the use of Health Economics and Outcomes Research (HEOR) and Real World Evidence (RWE) to support decision making on adoption of our innovative therapies across multiple stakeholders. To prepare for successful market access, argenx requires timely evidence of burden and value for Healthcare Decision Makers.
Argenx is committed to elucidating the burden of illness faced by patients and caregivers for the conditions we seek to address; generating and communicating evidence to answer questions from Healthcare Decision Makers including: regulators, payors, HCPs, patient advocacy organizations and other decision makers to accelerate appropriate patient access to our innovative therapies.
The HEOR: Real World Evidence (RWE) associate director will collaborate with internal and external stakeholders and decision makers to support the planning, design and execution of RWE programs of Argenx innovative therapies. Argenx seeks to generate RWE that fosters communication with regulators, payors and HTAs, HCPs, patient advocacy organizations and other stakeholders around the globe to communicate the burden of illness for diseases argenx seeks to treat and the value of argenx innovative therapies to address that burden.
The HEOR : RWE Associate Director will serve as an internal resource to support and lead RWE programs within cross functional teams, including HEOR scientists, Clinical Development, Medical Affairs, Market Access, Brand Marketing, Patient Advocacy, Business Development, Legal, and Regulatory to align evidence generation efforts with identified evidence gaps. This RWE associate director will have broad responsibility to support scientifically credible RWE projects leading cross functional teams including, when appropriate, external clinical and research experts as well as patient advocates.
This person will work closely with cross functional team members to effectively manage project scope, budget and timelines to produce and disseminate RWE for conditions of interest to argenx.
ROLES AND RESPONSIBILITIES
- Maintain RWE generation plans aligned with Medical, Market Access, and Brand Marketing strategies for demonstrating unmet patient need and the value of Argenx products to decision makers.
- Work with the HEOR RWE member(s) to identify, select and execute RWE projects, with consideration for regulatory and legal compliance.
- Support RWE studies by reviewing, protocols and SAPs; and reporting at scientific congresses, in peer reviewed publications, and proactive/reactive Argenx communication tools.
- In collaboration with the HEOR RWE Specialist(s) and EU Market Access create RWE that provides data to support HTA reviews.
- Effectively manage projects within scope, budget, and timelines to assure the evidence generated can support successful HTA and market access outcomes when appropriate.
- Collaborate with Sci Comm in development of publication plans for RWE studies integrated with the HEOR and clinical publication plan
- Act as an Argenx representative engaging with external stakeholders such as patient organizations and KOLs (in close collaboration with Patient advocacy and MRLs).
- Upon request, and in partnership with field Market Access and Medical Affairs, develop and deliver RWE presentations to external stakeholders.
SKILLS AND COMPETENCIES
- Communication : Listens and gets 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.
- Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
- 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 Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
- Priority setting: Effectively sets clear priorities among competing opportunities. Leverages experience and know-how to focus on priority objectives.
- Technical mastery: Has a thorough understanding of RWD collection projects and can manage them to successful delivery and a mastery of generating relevant impactful RWE.
- Knowledge of and experienced in different types of RWE studies, e.g. observational non-interventional studies, disease management and patient support programs, retrospective and prospective cohort studies, etc.
- 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.
- Strong communication and interpersonal skills
- Strong active listening skills with ability to incorporate input from a variety of stake- holders
- Knowledge of secondary data sources (surveys, claims data, electronic medical records, registries etc).
EDUCATION, EXPERIENCE AND QUALIFICATIONS
- Minimum 5 years consulting &/or working in pharmaceutical/biotech industry: Strong knowledge of pharmaceutical development, scientific project management, RWD collection, RWE generation, and regulatory requirements. Experience in HEOR preferred.
- Minimum 3 years RWE study experience: In depth understanding of project set up and execution from basic retrospective data analysis to full prospective study development, set up, and execution. RWE cross-functional team management and broad under- standing of use of RWE for maximum impact.
- Advanced degree in Health Economics, Outcomes Research, Pharmacoeconomics, Epidemiology, Health Services Research or related discipline is required (PhD, MS, MPH).
- Ability to travel up to 20% of time as needed