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 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 I implementation, problem solving and escalation. The CODL may lead the IDT, ensuring effective decision-making and team performance towards the indication and company Objectives, goals, strategies and measures (OGSMs).

ROLES AND RESPONSIBILITIES (non-exhaustive list)

• 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 Objectives, Goals, Strategies and Measures (OGSM).
• Accountable for the conduct of all clinical related aspects within the assigned therapeutic indication/program. Ensure the execution is done in line with the agreed OGSMs, timelines, budget, quality standards, ICH-GCP and applicable regulations, Standard Operation Procedures (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.
• In collaboration with the other IDT members, identifies risks, ensures that these are reflected in applicable risk registers and drives their mitigation. Works with the Project Manager (PM) and IDT members to decide which risks and issues are to be brought to the attention of the asset Project Leader (PL) and the Development Management Committee (DMC). Pro-actively provides solutions and oversees implementation and follow-up.
• Ensures that the Franchise Clinical Operations Development Lead (FCODL) and Global Head of Trial Operations are informed in case an identified issue/risk could have an impact on/may also occur in the other therapeutic indications/programs. In case of an asset specific impact, involve FCODL and peer CODL(s), AST, and PM as needed.
• Ensures consistency and efficiency in trial set-up and conduct across the different trials within the specific indication(s).
• Drives the timely production of a qualitative Clinical Trial Protocol Concept Sheet.
• Collaborates with the Clinical Trial Leads (CTLs) and Clinical Trial Managers (CTM) and their respective Clinical Trial Teams (CTTs) to ensure timely availability of qualitative documents defining the design and the execution of the clinical program (e.g. protocol/protocol amendments, operationalization plans and tools). Active CODL input to the CTT may be needed until the team is fully resourced.
•  Works towards initial country and site selection, oversees the actual selection and ensures  that the AST and IDT are kept informed on the final selection.
• Participates in the Clinical Research Organization (CRO) and collaborator/supplier selection and management process. Supports CTT with issue resolution in collaboration with alliance and sourcing manager if relevant.
• Reviews and provides input to the overarching clinical program/indication documents such as Pediatric Investigation Plan (PIP), Diversity Action Plan (DAP) and regulatory documents.
• Accountable for the clinical trial budgets and timelines and support resource requirements, collaborating with the indication Project Manager (PM), the Finance business partner (FBP) and the sourcing manager.

• Informs the IDT in case the timelines or budget deviate from projected and partners with IDT members to review and discuss status and impact of change(s), brings options forward to resolve these and ensure these are subject to governance endorsement as needed.
• Provide input to the program dashboards to ensure accurate status updates on key milestones achieved and planned, issues/risks and financial status.
• Ensures audit/inspection preparation and readiness of the assigned program/trials. Support audits and inspections.
• Supports continuous improvement processes and consistency e.g., by ensuring that lessons learned are shared across trials within the assigned therapeutic indication, across indications as well as across assets in collaboration with the FCODL and the Global Head of Trial Operations, if applicable.
• As a Leader, sets expectations, communicates in a transparent, clear way and energizes  team members to work towards achieving the project goals.
• Coaching of CTLs/CTMs:
  • On-boarding of new joiners
  • Goal setting and continuous feedback  
  • Mentoring and enabling the growth and development

• Support Trial Operations and Global Company initiatives (including interviewing candidates).
• Role models the argenx cultural pillars and operating principles: humility, co-creation, drives excellence and innovation, empowers team members.

SKILLS AND COMPETENCIES

• The CODL excels in leadership and establishing good and effective internal and external working relationships and communication, embedding the 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 - demonstrated ability to identify and resolve issues, identify and mitigate risks, able to handle conflicts.
• Strong organizational skills, able to deal with complexity and ambiguity, manage multiple and varied tasks and prioritize workload with attention to the holistic/ helicopter view but also able to dive into the details when needed.
• Strong people management skills, leadership skills and team player.
• Excellent written and verbal communication skills, acting 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 – medical or para-medical (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 in working in an outsourced model, including overseeing CROs and collaborators.
• Rare disease and/or auto-immune clinical trial background is a plus.