Franchise Clinical Operations Development Lead (CODL)

Accountabilities:

• • Lead and oversee Clinical Operations Development Leads responsible for clinical activities across assigned therapeutic indications, programs, or development phases, ensuring delivery against agreed timelines, budgets, quality standards, SOPs, and work instructions.
  • Oversee the creation and execution of Clinical Development Plans across the franchise, partnering with Medical Development Leads, Project Managers, and Clinical Development Team representatives to establish effective and innovative development strategies aligned with target product profiles.
  • Serve as the senior clinical operations point of contact for the franchise, providing strategic operational guidance across assets and indications and acting as an escalation point for complex trial-management and operational issues.
  • Identify franchise-level risks, dependencies, and opportunities, establish appropriate mitigation strategies, and escalate issues that could affect other indications, programs, or franchises.
  • Promote knowledge sharing, operational synergies, and consistent application of lessons learned across indication teams and broader Trial Operations.
  • Ensure clinical programs and trials are executed in accordance with development plans, organizational objectives, ICH-GCP requirements, applicable regulations, and established procedures.
  • Support CRO and vendor selection and oversight, working with clinical teams and relevant vendor-management partners to resolve issues and maintain effective external partnerships.
  • Review and contribute to key clinical and regulatory documents, including Investigator Brochures, Pediatric Investigation Plans, and critical submissions or materials for global health authorities.
  • Oversee clinical trial budgets, timelines, and resource requirements in partnership with Clinical Operations Development Leads and Clinical Trial Managers, ensuring appropriate staffing and resources are secured in a timely manner.
  • Maintain audit and inspection readiness across assigned programs and support regulatory inspections and audits as required.
  • Drive continuous improvement initiatives, operational consistency, and knowledge-management practices across the Trial Operations organization.
  • Lead, mentor, and develop Clinical Operations Development Leads through recruitment, onboarding, training, goal setting, performance management, coaching, and career development.
  • Set clear expectations and foster a transparent, collaborative, accountable, and results-oriented culture that motivates teams to achieve clinical development objectives.
  • Collaborate with stakeholders beyond Clinical and R&D, including corporate development, science, patient advocacy, medical affairs, and other functions to advance franchise-level priorities.
  • Contribute to broader Trial Operations and organizational initiatives as required.

  Requirements:

  • Bachelor’s or university degree in a medical, pharmaceutical, biological, biomedical, veterinary, or related field, or equivalent professional experience; a PhD is a plus.
  • 15+ years of relevant experience in clinical development, including clinical monitoring and local and global/international trial management.
  • Proven leadership experience within Clinical Operations in the pharmaceutical or biotechnology industry, including direct people management.
  • Demonstrated expertise in planning and executing clinical development strategies and clinical trials across complex programs.
  • Experience building, leading, mentoring, and developing teams with diverse functional expertise.
  • Strong experience working within outsourced clinical development models, including oversight and management of CROs and external vendors.
  • Ability to operate effectively at both strategic and execution levels, maintaining a broad franchise perspective while engaging deeply with operational details when necessary.
  • Strong expertise in change management, risk identification and mitigation, and complex problem solving.
  • Demonstrated financial acumen, including experience overseeing clinical budgets and resource planning.
  • Thorough knowledge of ICH-GCP guidelines and applicable clinical research regulations and requirements.
  • Experience in rare disease and/or autoimmune clinical trials is highly relevant and advantageous.
  • Exceptional leadership, communication, stakeholder-management, and relationship-building capabilities across functions, regions, and cultures.
  • Ability to build bridges between teams, functions, and geographies while creating alignment around shared clinical objectives.
  • Highly organized, proactive, and capable of managing multiple complex priorities in a dynamic environment.
  • Strong written and verbal English communication skills, with full professional proficiency required.

  Benefits:

  • Annual U.S. base salary range of $268,000–$368,500, with actual compensation determined by relevant experience, skills, competencies, and internal equity.
  • Eligibility to participate in short-term and long-term incentive programs, subject to applicable plan terms and policies.
  • Comprehensive benefits package including health benefits and retirement savings plans.
  • Remote work opportunities, including positions based in the United States.
  • Opportunity to contribute to the development of innovative clinical programs across multiple indications and development stages.
  • Global, cross-functional working environment with exposure to clinical, medical, regulatory, scientific, and commercial stakeholders.
  • Opportunities to lead, mentor, and develop clinical operations professionals while influencing organizational practices and capabilities.
  • Support for professional growth and continuous development within a science-driven biotechnology environment.
  • Inclusive workplace committed to equal opportunity and reasonable accommodations for qualified applicants.