Franchise Clinical Operations Development Lead

🔥 0 minutes ago

🌐 United States, Belgium, +1 more countries – Remote

🇺🇸 United States – Remote 🇧🇪 Belgium – Remote 🇨🇭 Switzerland – Remote

💵 $268k - $368.5k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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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

• Strategize, plan, lead, and execute the operational path for all indications within a franchise from first-in-human studies through authorization and commercialization • Line-manage Clinical Operations Development Leads assigned to indications within the franchise or development-phase teams • Provide a clinical strategic operational voice for the franchise internally and externally • Oversee CODLs’ strategic input and accountability for clinical activities within therapeutic indications/programs, aligned with timelines, budget, quality standards, SOPs, and WIs • Oversee creation and execution of Clinical Development Plans for all franchise indications • Serve as senior point of contact for clinical activities across franchise asset indications • Identify franchise-level risks and mitigations and escalate cross-franchise issues as needed • Operationalize knowledge and synergies across indication teams and franchises • Provide input to OGSMs and ensure trials follow CDPs, argenx processes, ICH-GCP, and applicable legislation • Participate in CRO and vendor selection and management • Support issue resolution and act as escalation point for trial management and operational issues • Review and provide input on clinical program, indication, and regulatory documents • Oversee indication and clinical trial budgets, timelines, and Trial Operations resource requirements • Ensure audit and inspection readiness and support audits and inspections • Support continuous improvement and knowledge-sharing initiatives • Lead, motivate, onboard, train, set goals for, review, mentor, and develop CODLs • Support Trial Operations and global company initiatives • Collaborate with stakeholders outside Clinical and R&D, including Corporate Development, Science, Patient Advocacy, and Medical Affairs

🎯 Requirements

• Proven track record in relevant leadership positions, including line management, within Clinical Operations in pharmaceutical/biotech industries • Proven knowledge of planning and executing clinical development plans and clinical trials • Experience building and leading teams with varied skill sets • Ability to build bridges between people, functions, and regions • Proactive problem-solving, issue identification and resolution, risk mitigation, and conflict management • Strong organizational skills and ability to manage multiple varied tasks and prioritize workload • 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 applicable regulatory requirements and guidelines • Bachelor’s or university degree in a medical or paramedical field, such as Biology, Biomedical Sciences, Pharmacy, or Veterinary Medicine, or equivalent experience • PhD degree is a plus • Minimum 15 years of leading experience in Clinical Development, including monitoring and local/global/international trial management • Experience working in an outsourced model, including overseeing CROs and vendors • Experience with clinical development strategy and execution • Change and risk management experience • Budget financial acumen • Rare disease and/or autoimmune clinical trial background relevant to the franchise

🏖️ Benefits

• Short-term incentive programs • Long-term incentive programs • Comprehensive benefits package • Retirement savings plans • Health benefits • Equal consideration in an inclusive environment • Reasonable accommodation in completing the application, interviewing, or otherwise participating in the candidate selection process • Opportunities for growth • Meaningful work • Once-in-a-career experiences