Director, Patient Services QA & Administration

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 Director, Patient Service QA and Administration is a critical role in the argenx Patient Services team. Under the direction of the Head of Patient Services, the Director, Patient Service QA and Administration is responsible for the overarching components common to all Patient Support Program functions and offerings. This includes, but is not limited to, PSP quality assurance, PSP vendor contracting and onboarding, pharmacovigilance, primary point of contact to training organization, and primary internal/external audit/inspection lead.  This individual will be also accountable for development of corrective action/remediation plans, documentation, pharmacovigilance reconciliation, and ensuring PSP is audit/inspection ready.

In addition to being a key member of the argenx PSP leadership team, this individual will develop and maintain a high level of collaboration and integration with key cross-functional argenx staff, including HUB, Nurse Case Manager, PSP Analytics, Business Information Systems (BIS), Training, and Global Safety and Global Quality. The position is remote and requires a highly motivated individual who can work cross-functionally to accomplish objectives.

By executing the following duties, help ensure best in class support to health care providers and patients in accessing medically necessary treatments, understanding drug administration procedures, complying and adhering to prescribed treatment to ensure safety, and minimizing reimbursement obstacles that may impede treatment access:

Roles and Responsibilities:
•    Develop and evolve the PSP quality assurance program, ensuring program execution matches key SOP / Work Instruction standards and key customer/patient experience standards.  When gaps in SOP/WI are found, recommends revision to leadership team
•    Develop and manage a customer satisfaction / Net Promoter survey program for Patient Services
•    Provide periodic metrics and reporting on quality assurance and customer satisfaction results/insights
•    Collaborate with Patient Services leadership to develop corrective action/remediation plans, and inform process documentation efforts
•    Collaboration with training department to ensure opportunities identified in QA are appropriately remediated and included in core training for new hires as appropriate
•    Supervise and track compliance with all team trainings, credentialing, and licensing requirements
•    Provide leadership with updates on policy developments and likely impacts on patients and delivery services
•    Vendor management:  Ensure key contractual language exists in vendor contracts for items such as pharmacovigilance, business continuity, user access control, data privacy, etc by engaging with key internal matrix partners.  Manage key contractual dates/timelines.  Ensure all necessary functions are consulted as contracts are implemented and revised (legal, compliance, safety, quality, finance, etc).
•    Pharmacovigilance:  Ensure Patient Services remains in compliance with key pharmacovigilance requirements through ensuring all employees and contractors have received required training, that all employees/contractors are compliant with adverse event and product complaint reporting, and that all remediation efforts are carried out per SOPs
•    Acts as lead for internal/external audit/inspection readiness and acts as key interface with auditors/inspectors on behalf of the department.  Ensures all necessary documentation is collected and maintained to support an audit/inspection at any time (i.e., org charts, job descriptions, CVs, training records, SOPs/work instructions, CAPAs, etc)

Skills and Competencies:
The candidate must demonstrate cross-functional leadership through the execution of complex and innovative project management. Other critical success factors include:
•    Ability to collaborate with senior executives in support of key initiatives
•    Proactively and independently prioritize requests and business needs
•    Ability to facilitate cross-functional collaboration (e.g., Analytics, BIS, Training, Compliance, Legal, etc.)
•    Must possess excellent organizational and communication skills. This includes demonstrating an understanding of how to escalate issues/concerns, and effectively communicate with others, especially those in other functional areas
•    Strong consulting, meeting management and group process facilitation skills are required to achieve pre-defined objectives
•    Strong leadership skills and ability to influence/lobby internal and affiliate decision-makers

Education, Experience and Qualifications:
•    Experience in specialty products and specialty product launches required
•    Strong and effective presentation and communication skills
•    Ability to travel occasionally
•    Salesforce.com Healthcloud database experience preferred
•    Knowledge of applicable regulations and standards affecting pharmaceutical products specifically related to patient service programs.
•    5+ years of "progressive" industry/relevant professional experience; 5+ years working for a pharmaceutical manufacturer with minimum 2 years in patient services.
•    Bachelor's degree required
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