Clinical Operations Development Lead

🕒 August 6

🌐 United States, Belgium – Remote

🇺🇸 United States – Remote 🇧🇪 Belgium – Remote

💵 $212k - $291.5k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• Oversee clinical-related activities within a specific therapeutic indication or across all indications for an asset • Co-lead the Clinical Development Team with the Medical Development Lead and co-own the Clinical Development Plan • Work with the Asset Strategy Team, Medical Development Lead, and Project Manager to integrate cross-functional information • Build and coordinate Clinical Development Teams with representatives from involved functional areas • Drive execution of clinical programs in collaboration with Clinical Development Team members • Oversee clinical trial budgets, contribute to timeline and resource requirements, and provide financial planning input • Monitor budget and timeline deviations, risks, mitigations, and plan adjustments with the Project Manager • Maintain oversight and serve as primary contact for Clinical Development Plan activities throughout the compound lifecycle • Lead Clinical Development Team meetings and ensure outcomes, actions, conclusions, and minutes are established • Ensure clinical trials are executed according to the Clinical Development Plan, OGSMs, argenx procedures, ICH-GCP, and applicable legislation • Identify, document, and mitigate risks affecting team goals, timelines, or spending • Ensure consistency and efficiency in trial setup and conduct across trials • Drive production of Clinical Trial Concept Sheets and clinical program documents • Collaborate with Clinical Trial Managers and trial teams on protocols, amendments, operationalization plans, and tools • Coordinate country and site selection with the Countries and Sites Selection Commission and relevant teams • Participate in CRO and vendor selection and management • Escalate and resolve trial management and operational issues • Review clinical program, indication, investigator, pediatric, and regulatory-critical documents • Review program dashboards and provide accurate milestone, risk, issue, and financial status updates • Ensure audit and inspection readiness and support audits and inspections • Drive continuous improvement and sharing of lessons learned across trials, indications, and compounds • Set expectations, communicate transparently, and motivate Clinical Development Team members and Clinical Trial Managers • If applicable, manage Clinical Trial Managers and/or Clinical Trial Associates, including interviewing, onboarding, training, goal setting, mentoring, and development • Support Clinical Operations and global company initiatives as applicable

🎯 Requirements

• 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 or biotech industry • Ability to identify and resolve issues, mitigate risks, and handle conflicts • Strong organizational skills with ability to manage multiple varied tasks and prioritize workload • Strong people management and leadership skills • Excellent written and verbal communication skills in a culturally diverse global team • Strong verbal and written English communication skills, with primary fluency or full professional proficiency • Thorough knowledge of ICH-GCP guidelines and other applicable regulatory requirements and guidelines • Bachelor’s degree or university degree in medical or para-medical fields such as Biology, Biomedical Sciences, Pharmacy, or Veterinary, or equivalent by experience • Minimum of 10 years of leading experience in Clinical Development, including monitoring and local and global/international trial management • Experience working in an outsourced model, including overseeing CROs and vendors • Rare disease and/or autoimmune clinical trial background is a plus • Line management experience is a plus

🏖️ Benefits

• Short-term and long-term incentive programs • Comprehensive benefits package • Retirement savings plans • Health benefits • Equal consideration for employment without discrimination • Reasonable accommodation in completing the application, interviewing, or participating in the candidate selection process