[Hiring] Franchise Clinical Operations Development Lead @argenx

Role Description

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. The Franchise Clinical Operations Development Lead (CODL) is responsible for the strategizing, planning, leading, and execution of the operational path for all indications within a franchise from first in human studies through authorization and commercialization.

• Oversee the CODLs who provide strategic input and are accountable for all clinical related aspects within the assigned therapeutic indication/program.
• Oversee the Clinical Development Plan (CDP) creation for all indications within the franchise.
• Acts as senior point of contact for all clinical related activities for a given Franchise across asset indications.
• Focus on risks and mitigations on the franchise level.
• Operationalize knowhow and synergies at the franchise level.
• Ensure optimal implementation of lessons learnt within and across the franchises.
• Provides input to the relevant Objectives, Goals, Strategies and Measures (OGSMs).
• Participates in the Clinical Research Organization (CRO) and vendor selection and management process.
• Acts as a point of escalation for resolution of trial management and operational issues.
• Reviews and provides input to the overarching clinical program/indication documents.
• Oversees the Indication and clinical trial budgets and timelines.
• Oversees the resource requirements for Trial Operations within the franchise.
• Oversees audit/inspection readiness of the assigned program/trials.
• Supports continuous improvement processes and consistency.
• Sets expectations, communicates clearly, and motivates the CODLs and CTMs.
• Acts as line manager for the CODLs and leader within the Trial Ops team.
• Collaborate on the franchise level with stakeholders outside of Clinical and R&D.

Qualifications

• Proven track record in relevant leadership positions, including line management, within Clinical Operations in the pharmaceutical/biotech industries.
• Proven knowledge of planning and execution of clinical development plans and clinical trials.
• Experience in building and leading a team with a variety of skill sets.
• Strong organizational skills, able to manage multiple and varied tasks.
• Excellent written and verbal communication skills.
• Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements.

Requirements

• Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience. PhD degree is a plus.
• Minimum of 15 years of leading experience in Clinical Development.
• Experience in working in an outsourced model, including overseeing CROs and vendors.
• Strategy as well as execution for clinical development.
• Change and risk management.
• Budget financial acumen.
• Rare disease and/or auto-immune clinical trial background relevant to the franchise.

Benefits

• Comprehensive benefits package, including retirement savings plans and health benefits.
• Eligible to participate in short-term and long-term incentive programs.

Company Description

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.