Clinical Operations Development Lead

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

Résumé du poste

argenx SE is seeking a Clinical Operations Development Lead (CODL) in Belgium, Oost-Vlaanderen. This key position oversees clinical activities for specific therapeutic indications and provides strategic input across the development lifecycle from First in Human studies to post-approval activities.

The ideal candidate has extensive leadership experience in clinical development, strong communication skills, and a solid background in global drug development, ensuring compliance and successful execution of clinical trials.

Qualifications

• Minimum of 15 years of leadership experience in clinical development.
• Experience in overseeing CROs and collaborators in an outsourced model.
• Knowledge of ICH-GCP guidelines and applicable regulatory requirements.

Responsabilités

• Manage clinical trial budgets, timelines, and resources.
• Drive operational risk management and problem solving.
• Ensure compliance with quality standards and regulations.
• Lead the Clinical Development Plan in collaboration with IDT.
• Support audit and inspection readiness of assigned trials.

Connaissances

Leadership

Communication skills

Interpersonal skills

Stakeholder management

Problem-solving

Organizational skills

Team-building

English proficiency

Formation

Bachelor’s or master’s degree in a medical or para-medical field

Description du poste

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

• Manage clinical trial budgets, timelines and resources (including line management) and provide input to trial design and regulatory authority strategy and interactions.
• Drive operational risk management, cross‑functional integration, problem solving and escalation.
• Lead the IDT when required, ensuring effective decision‑making and team performance toward the indication and company Objectives, Goals, Strategies and Measures (OGSMs).
• Provide operational expertise and strategic input to the Clinical Development Plan (CDP) in collaboration with other IDT representatives.
• Ensure the CDP describes a clinical development strategy that is innovative, effective, and consistent with the Target Product Profile (TPP).
• Provide input to the Objectives, Goals, Strategies and Measures (OGSM).
• Be accountable for the conduct of all clinical‑related aspects within the assigned therapeutic indication/program.
• Ensure execution is compliant with OGSMs, timelines, budget, quality standards, ICH‑GCP, applicable regulations, SOPs and Work Instructions (WIs).
• Act as primary point of contact for all operational clinical‑related activities at indication level and as escalation point for trial‑level activities.
• Identify risks in collaboration with other IDT members, ensure they are reflected in risk registers and drive mitigation.
• Work with the Project Manager (PM) and IDT members to decide which risks and issues are brought to the asset Project Leader (PL) and Development Management Committee (DMC).
• Proactively provide solutions, oversee implementation and follow‑up.
• Ensure that the Franchise Clinical Operations Development Lead (FCODL) and Global Head of Trial Operations are informed when an identified issue/risk could impact other therapeutic indications/programs.
• In asset‑specific impacts, involve FCODL, peer CODLs, AST and PM as needed.
• Ensure consistency and efficiency in trial set‑up and conduct across different trials within the specific indication(s).
• Drive the timely production of a qualitative Clinical Trial Protocol Concept Sheet.
• Collaborate with Clinical Trial Leads (CTLs), Clinical Trial Managers (CTMs) and Clinical Trial Teams (CTTs) to ensure timely availability of qualitative documents defining the design and execution of the clinical program (protocol, protocol amendments, operationalization plans and tools).
• Provide CODL input to the CTT until the team is fully resourced.
• Work toward initial country and site selection, oversee the actual selection and ensure the AST and IDT are kept informed of the final selection.
• Participate in CRO and collaborator/supplier selection and management processes.
• Support the CTT with issue resolution in collaboration with alliance and sourcing manager if relevant.
• Review and provide input to overarching clinical program/indication documents such as Pediatric Investigation Plan (PIP), Diversity Action Plan (DAP) and regulatory documents.
• Accountable for clinical trial budgets and timelines and support resource requirements, collaborating with the indication PM, Finance Business Partner (FBP) and sourcing manager.
• Inform the IDT when timelines or budget deviate from projections and partner with IDT members to review status and impact of changes, propose options to resolve issues and ensure governance endorsement as needed.
• Provide input to program dashboards to ensure accurate status updates on key milestones, issues/risks and financial status.
• Ensure audit/inspection preparation and readiness of the assigned program/trials.
• Support audits and inspections.
• Support continuous improvement processes and consistency by sharing lessons learned across trials within the assigned therapeutic indication, across indications and across assets in collaboration with FCODL and the Global Head of Trial Operations.
• As a leader, set expectations, communicate transparently and clearly, and energize team members toward achieving project goals.
• Coach CTLs/CTMs: onboard new joiners, set goals, provide continuous feedback, mentor and enable growth and development.
• Support Trial Operations and global company initiatives, including interviewing candidates.
• Role‑model the argenx cultural pillars and operating principles: humility, co‑creation, drive excellence and innovation, and empower team members.

Skills and Competencies

• Leadership and strong internal and external working relationships and communication, embedding argenx values.
• Global strategic drug development experience and understanding.
• Strong interpersonal and stakeholder management skills.
• Proven clinical operations experience in a relevant global leadership position in the pharmaceutical/biotech industry.
• Pro‑active problem solver with demonstrated ability to identify and resolve issues, mitigate risks and handle conflicts.
• Strong organizational skills, able to manage complexity, ambiguity, multiple tasks and prioritize workload with a holistic view while diving into details when needed.
• Strong people‑management and team‑building skills.
• Excellent written and verbal communication skills, operating globally in a culturally diverse dynamic team.
• Strong literacy in English.
• Thorough knowledge of ICH‑GCP guidelines and other applicable regulatory requirements and guidelines.

Education, Experience and Qualifications

• Bachelor’s or master’s degree in a medical or para‑medical field (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or equivalent by experience.
• Minimum of 15 years of leadership experience in clinical development (monitoring, local and global/international trial management).
• Experience working in an outsourced model, including overseeing CROs and collaborators.
• Rare‑disease and/or autoimmune clinical trial background is a plus.