Franchise Clinical Operations Development Lead

This is a fully remote position, open to applicants in United States, +2 more countries.

📋 Description

• Develop, strategize, lead, and implement the operational roadmap for all indications within a franchise, spanning from first-in-human studies to authorization and commercialization.

• Manage Clinical Operations Development Leads assigned to indications within the franchise or development-phase teams.

• Serve as the clinical strategic operational authority for the franchise, both internally and externally.

• Supervise the strategic input and accountability of CODLs for clinical activities within therapeutic indications/programs, ensuring alignment with timelines, budget, quality standards, SOPs, and WIs.

• Oversee the formulation and execution of Clinical Development Plans for all indications within the franchise.

• Act as the senior point of contact for clinical activities across franchise asset indications.

• Identify risks at the franchise level and propose mitigations, escalating cross-franchise issues as necessary.

• Facilitate the operationalization of knowledge and synergies across indication teams and franchises.

• Contribute to OGSMs and ensure compliance of trials with CDPs, argenx processes, ICH-GCP, and relevant legislation.

• Engage in the selection and management of CROs and vendors.

• Assist in resolving issues and serve as an escalation point for trial management and operational challenges.

• Review and provide insights on clinical program, indication, and regulatory documents.

• Manage indication and clinical trial budgets, timelines, and resource requirements for Trial Operations.

• Ensure readiness for audits and inspections while supporting the audit process.

• Promote continuous improvement and share knowledge initiatives.

• Lead, inspire, onboard, train, set performance goals for, review, mentor, and develop CODLs.

• Support Trial Operations and broader company initiatives.

• Collaborate with stakeholders outside of Clinical and R&D, including Corporate Development, Science, Patient Advocacy, and Medical Affairs.

⛳️ Requirements

• Demonstrated success in relevant leadership roles, including line management, within Clinical Operations in the pharmaceutical/biotech sectors.

• Established expertise in planning and executing clinical development plans and clinical trials.

• Experience in building and leading teams with diverse skill sets.

• Ability to foster connections between individuals, functions, and geographical regions.

• Proactive in problem-solving, issue identification, resolution, risk mitigation, and conflict management.

• Strong organizational abilities with the capacity to manage multiple tasks and prioritize workload effectively.

• Exceptional written and verbal communication skills in a culturally diverse global team setting.

• Proficient in English communication, both verbal and written, with primary fluency or full professional proficiency.

• In-depth understanding of ICH-GCP guidelines and relevant 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.

• A PhD degree is advantageous.

• At least 15 years of leadership experience in Clinical Development, including monitoring and managing local/global/international trials.

• Experience in an outsourced model, including oversight of CROs and vendors.

• Familiarity with clinical development strategy and execution.

• Experience in change and risk management.

• Financial acumen in budgeting.

• Background in rare disease and/or autoimmune clinical trials 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 accommodations provided for application, interviews, or participation in the candidate selection process.

• Opportunities for professional growth.

• Engaging and meaningful work.

• Unique experiences that are once-in-a-career.