Clinical Operations Development Lead

argenx; Oost-Vlaanderen; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

A global biotech company is seeking a Clinical Operations Development Lead in Oost-Vlaanderen. This role entails overseeing clinical activities for therapeutic indications, managing trial budgets, and ensuring compliance with standards. Candidates should possess strong leadership and communication skills, alongside a minimum of 15 years of experience in clinical development. The position demands a bachelor’s or master’s in medical fields, with a focus on innovation and excellence.

Qualifications

• Minimum of 15 years of leadership experience in Clinical Development.
• Experience in outsourced models, including CRO oversight.
• Familiarity with ICH-GCP and regulatory guidelines.

Responsabilités

• Provide operational expertise and strategic input to Clinical Development Plan.
• Account for all clinical-related aspects in assigned program.
• Ensure consistency in trial setup and conduct across trials.

Connaissances

Leadership

Communication

Relationship-building

Problem Solving

Organizational Skills

Team Leadership

Stakeholder Management

Proficiency in English

Formation

Bachelor’s or master’s degree in medical or para-medical fields

Description du poste

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The Clinical Operations Development Lead (CODL) is a key member of the Indication Development Team (IDT), overseeing clinical activities for a specific therapeutic indication (CODL) or across all indications for an asset (early/late phase CODL). The CODL provides operational input and drives strategy for clinical development across the lifecycle of an asset, from First in Human (FIH) studies through registration and post-approval clinical development activities. Responsibilities include but are not limited to: managing clinical trial budgets, timelines, and resources (including line management), and providing input to trial design and regulatory authority strategy and interactions. The CODL drives operational risk management, cross-functional implementation, problem solving and escalation. The CODL may lead the IDT, ensuring effective decision-making and team performance towards the indication and company OGSMs (Objectives, Goals, Strategies and Measures).

Responsibilities

• Provides operational expertise and strategic input to the Clinical Development Plan (CDP) in collaboration with other IDT representatives. Ensures the CDP describes the clinical development strategy, comprising effective and, where possible, innovative trial designs and is consistent with the Target Product Profile (TPP).
• Provides input to the OGSM and ensures alignment with program goals.
• Accountable for the conduct of all clinical-related aspects within the assigned therapeutic indication/program. Ensure execution is in line with OGSMs, timelines, budget, quality standards, ICH-GCP and applicable regulations, SOPs and WIs.
• Act as primary point of contact for all operational clinical-related activities at the indication level and as escalation point for trial-level activities.
• In collaboration with other IDT members, identify risks, maintain risk registers, and drive mitigation. Work with the Project Manager (PM) and IDT to determine which risks and issues require escalation to the asset Project Leader (PL) and the Development Management Committee (DMC). Pro-actively provide solutions and oversee implementation and follow-up.
• Ensure that the FCODL and Global Head of Trial Operations are informed of issues/risks with potential cross-indication impact. In asset-specific cases, involve peers as needed.
• Ensure consistency and efficiency in trial setup and conduct across trials within the indication(s).
• Drive the timely production of a qualitative Clinical Trial Protocol Concept Sheet.
• Collaborate with Clinical Trial Leads (CTLs) and Clinical Trial Managers (CTMs) to ensure timely availability of documents defining design and execution (e.g., protocol amendments, operationalization plans and tools). Active CODL input to the CTT may be needed until the team is fully resourced.
• Support initial country and site selection and ensure AST and IDT are informed of final selections.
• Participate in CRO and collaborator/supplier selection and management. Support CTT with issue resolution in collaboration with alliance and sourcing manager where relevant.
• Review and provide input to overarching clinical program documents (e.g., Pediatric Investigation Plan (PIP), Diversity Action Plan (DAP), regulatory documents).
• Accountable for clinical trial budgets and timelines; support resource requirements, collaborating with the indication PM, Finance partner (FBP) and sourcing manager.
• Inform the IDT of timeline or budget deviations and work with IDT members to review status, discuss impact, and propose options for governance endorsement as needed.
• Provide input to program dashboards to ensure accurate status updates on milestones, issues/risks, and financial status.
• Ensure audit/inspection readiness for assigned programs/trials and support audits and inspections.
• Support continuous improvement by sharing lessons learned across trials, indications, and assets, in collaboration with FCODL and Global Head of Trial Operations where applicable.
• As a leader, set expectations, communicate clearly, and energize team members to achieve project goals.
• Coaching of CTLs/CTMs, including onboarding new joiners, goal setting, feedback, mentoring, and enabling growth; support Trial Operations and Global Company initiatives (including interviewing candidates).
• Role model argenx values: humility, co-creation, excellence, innovation, and empowerment of team members.

Skills And Competencies

• Leadership with strong internal and external relationship-building and communication, aligning with argenx values.
• Global strategic drug development experience and understanding.
• Strong interpersonal and stakeholder management skills.
• Proven Clinical Operations leadership experience in a global pharmaceutical/biotech setting.
• Proactive problem solver with ability to identify and mitigate risks and resolve conflicts.
• Strong organizational skills with the ability to manage complexity, prioritize workload, and balance big-picture with detail orientation.
• People management and team leadership capabilities.
• Excellent written and verbal communication; effective in a diverse global team.
• Strong proficiency in English; familiarity with ICH-GCP and regulatory guidelines.

Education, Experience And Qualifications

• Bachelor’s or master’s degree in medical or para-medical fields (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or equivalent by experience.
• Minimum of 15 years of leadership experience in Clinical Development (monitoring, local and global trial management).
• Experience in outsourced models, including CRO oversight and collaboration.
• Rare disease and/or autoimmune clinical trial background is a plus.

Seniority level

• Director

Employment type

• Full-time

Job function

• Management and Manufacturing

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