Join Us in Transforming Immunology
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.
Role Overview
This role is part of the Site and Patient Engagement team within Trial Operations at argenx. The Manager, Site & Patient Engagement is responsible for overseeing and implementing communication strategies to recruit and retain participants in multiple clinical trials/indications across argenx.
Roles and Responsibilities
Project Management
- Collaborate closely with study teams and vendors to ensure successful project execution specific within the scope of S&PE.
- Oversee the activities of recruitment vendors and manage relationships with communication platform vendors involved in the development of study tools.
- Lead and manage recruitment and retention strategies for global clinical studies from inception to completion.
- Develop project plans and timelines in coordination with the Patient Recruitment & Retention Strategy Lead.
- Coordinate with stakeholders to align on project scope and objectives, ensuring smooth execution.
- Monitor project progress, identifying and implementing adjustments as necessary to achieve project goals.
Patient Recruitment & Retention
- Develop site & patient recruitment and retention materials to effectively convey the importance of study participation and adherence.
- Leverage recommended communication tools and technologies to support the recruitment and retention strategy, where applicable.
- Ensure all communications are clear, accurate, and compliant with healthcare regulations.
- Align with Site & Patient Engagement Lead to implement patient recruitment and retention strategies.
Internal Management of Material Development
- Facilitate effective communication among CODL’s, CTM’s, GPA, MA and other CTT members to incorporate feedback on relevant materials based on the “Patient Engagement Playbook.”
- Be the first point of contact for all patient recruitment and retention materials for global clinical studies (including study-specific website, lay summaries and any external communication specific to the study, where applicable).
- Collaborate with the Patient Recruitment & Retention Strategy Lead to develop and support trial-specific strategies.
External Communication
- Manage communication with external stakeholders, including CRO’s, design vendors, recruitment & retention vendors.
- Support the management of public-facing study information, such as study websites, plain language summaries (when applicable for a particular study).
- Design and edit study newsletters/newsflashes in conjunction with the clinical trial team (when applicable).
- Finalize the layout of study newsletters/newsflashes layout and obtain distribution approval.
- Assist the Clinical Trial Team with the design of presentations for Investigator Meetings.
Compliance and Quality Assurance
- Ensure all communication practices comply with healthcare regulations and organizational policies.
- Conduct regular reviews and audits of communication processes to maintain high standards of quality and compliance.
Data and Reporting
- Collect and analyze data related to recruitment and retention metrics, and report progress to study teams.
- Prepare reports and presentations for clinical trials operations management.
- Identify trends and areas for improvement based on data analysis.
- Provide recommendations for optimizing recruitment and retention efforts based on data insights.
Education, Experience and Qualifications
- Minimum of a BA or BS Degree in scientific, marketing or communications discipline.
- 5-7 years of relevant industry experience (pharma, biotech, CRO) required.
- Thorough understanding of clinical operations.
- Excellent oral and written communication skills and diplomacy to convey information.
- Ability to work collaboratively with multidisciplinary teams in a global environment.
- Excellent written and verbal communication skills.
- Knowledge of healthcare regulations and compliance standards.
- Auto-immune and/or oncology clinical trial background is a plus.
Skills and Competencies
- Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial.
- Ability to work with vendors and external stakeholders with timely communications.
- Highly organized with a positive attitude; works well through change and shifting priorities.
- Strong planning, organizational and project management skills.
- Ability to communicate effectively and professionally.
Equal Opportunity Employment
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.