Trial Operations Excellence

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

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 leadershi