Trial Operations Excellence & Innovation Lead

argenx SE; Northern (KY); Hybrid; USD 180,000 - 280,000; Full time

Job summary

argenx SE is seeking a Director, Trial Operations Excellence & Innovation Lead to shape and execute a strategic transformation agenda for Clinical Trial Operations. You will drive capabilities such as imaging, DHT, decentralized trials, automation, and AI-enabled processes while ensuring inspection readiness and scalable portfolio growth.

The role requires leading cross-functional teams, delivering measurable outcomes, and partnering with CROs to push operational innovation in alignment with

Qualifications

• Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Pharmacy, Nursing, Medicine, or related discipline.
• Minimum 12 years of global clinical operations experience.
• Experience leading strategic change initiatives across multiple functions and geographies.
• Strong experience with clinical trial technology platforms and operational innovation.
• Strong understanding of ICH GCP, global regulations, and sponsor oversight requirements.

Responsibilities

• Provide strategic leadership to define and execute the Trial Operations transformation roadmap.
• Identify future capability requirements to support portfolio growth and complex trial designs.
• Position as a thought leader for innovative trial operations approaches and emerging technologies.
• Translate strategic priorities into executable programs with measurable outcomes.
• Establish governance frameworks and present progress to senior leadership.
• Lead Centers of Excellence for imaging, DHT, Wearables, and decentralized trial methodologies.
• Collaborate with cross-functional teams to operationalize new capabilities and drive harmonization across assets.

Skills

Strategic leadership

Drug development & trials

Operational excellence

Stakeholder management

Business acumen

Change management

Analytical skills

Education

Bachelor's or Master's in Life Sciences

Job description

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.

Purpose of the Function

The Director, Trial Operations Excellence & Innovation Lead is responsible for shaping and executing the strategic transformation agenda for Clinical Trial Operations and ensuring organizational readiness in line with argenx vision. The role provides strategic leadership across Trial Operations and partner roles to identify, prioritize, and operationalize future capabilities, including imaging, Digital Health Technologies (DHT), decentralized trial capabilities, automation, AI-enabled operational processes, and emerging trial execution models. As a key member of the Trial Operations leadership team, this individual ensures that argenx remains at the forefront of operational innovation while enabling sustainable portfolio growth, inspection readiness, and exceptional trial execution.

Reporting Line

The Trial Operations Excellence & Future Capabilities Lead reports to the Global Head Trial Operations. Direct reports include: Lead Operational Excellence; eCOA Center of Excellence personnel; Future capability project leads as assigned; X-indication COL ROLES AND RESPONSIBILITIES (non-exhaustive list):

• Strategic Leadership & Future Readiness
• Define and execute the Trial Operations strategic transformation roadmap aligned with argenx vision.
• Identify future capability requirements needed to support portfolio growth, increasingly complex trial designs, and evolving regulatory expectations.
• Serve as a thought leader for innovative trial operations approaches and emerging technologies, including but not limited to AI technology.
• Translate strategic priorities into executable programs with measurable business outcomes.
• Partner with Trial Operations leadership to establish long-term operational capability plans.
• Establish a continuous improvement culture throughout Trial Operations.
• Drive standardization, simplification, and optimization of operational processes.
• Sponsor and oversee major process improvement initiatives.
• Center of Excellence Leadership - Act as a thought partner to the eCOA Center of Excellence Lead.
• Establish and lead Centers of Excellence for emerging operational capabilities including imaging, Digital Health Technologies (DHT), Wearables and remote monitoring solutions; Hybrid and decentralized trial methodologies; AI-enabled operational tools.
• Develop implementation frameworks enabling scalable adoption across the portfolio.
• Cross-Asset Strategic Initiatives - Oversee x-asset and x-indication strategic initiatives that require coordinated execution across multiple development programs.
• Partner with Asset Teams, CODLs, FCODLs, and Program Leadership to identify opportunities for harmonization and standardization.
• Drive portfolio-wide solutions that reduce operational complexity and accelerate development timelines.
• Serve as the primary Trial Operations representative for enterprise-wide operational transformation initiatives and act as the primary point of contact for (CRO) partners to drive innovation & digital transformation.
• Ensure lessons learned and best practices are systematically leveraged across assets and indications.
• Capability Development & Innovation - Continuously evaluate external industry trends, technologies, and best practices.
• Collaborate with Digital, Clinical Development, Biometrics, Medical Affairs, Regulatory, and Quality teams to operationalize new capabilities.
• Assess emerging solutions for feasibility, scalability, risk, and business benefit.
• Lead proof-of-concept activities and operational deployment plans.
• Develop implementation strategies that balance innovation with operational simplicity and regulatory compliance.
• Governance & Stakeholder Leadership - Establish governance frameworks for strategic initiatives and Centers of Excellence.
• Present recommendations and progress updates to senior leadership.
• Ensure alignment across capabilities, indications, and cross-functional stakeholders.
• Facilitate decision-making for complex and enterprise-level prioritization topics.
• Act as an escalation point for strategic operational challenges.
• Represent Trial Operations in relevant cross-functional governance forums and strategic discussions to ensure operational perspectives are integrated into enterprise decisions, capability roadmaps, and portfolio prioritization.

Skills and Competencies

• Strategic leadership with the ability to define and execute transformational change.
• Strong understanding of drug development and global clinical trial execution.
• Demonstrated operational excellence and process improvement expertise.
• Strong stakeholder management and influencing skills across all organizational levels.
• Excellent business acumen and portfolio-level thinking.
• Strong change management and organizational transformation capabilities.
• Strong analytical and problem-solving skills.

Education, Experience and Qualifications

Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Pharmacy, Nursing, Medicine, or related discipline. Minimum 12 years of global clinical operations experience. Demonstrated experience leading strategic change initiatives across multiple functions and geographies. Strong experience with clinical trial technology platforms and operational innovation. Strong understanding of ICH GCP, global regulations, and sponsor oversight requirements. Candidates must be based in Belgium, Switzerland or US (EST time zone) to be considered for this role.

This job is eligible to participate in our short-term and long-term incentives program. The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.

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.

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argx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam.

argx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argx that (i) were not solicited or requested by argx's internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argx and the firm, recruiter, or agency, may be pursued by argx and are ineligible for payment of referral or other fees.