Clinical Operations Development Lead

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $212k - $291.5k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🧬 Biotechnology

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

• Responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset. • Co-leads the Clinical Development Team (CDT) and co-owns the Clinical Development Plan (CDP). • Ensures that all relevant information from all functions within the AST and CDT are brought to the table. • Responsible for the clinical development strategy, ensuring execution of the CDP once endorsed by the AST. • Oversees the clinical trial budgets, contributes to timeline and resource requirements and provides input to the financial CDT planning. • Partners with the PM to review status and impact of change and to discuss options to resolve issues and mitigate risks.

🎯 Requirements

• Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience. • Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global/international trial management). • Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry. • Strong interpersonal and stakeholder management Skills. • Experience in working in an outsourced model, including overseeing CROs and vendors. • Rare disease and/or auto-immune clinical trial background is a plus. • Strong verbal and written English communication skills (primary fluency or full professional proficiency).

🏖️ Benefits

• Health benefits • Retirement savings plans • Short-term and long-term incentive programs