About the Role
Drive operational strategy and execution for late-stage clinical programs. Ensure efficient trial conduct by managing timelines, resources, and compliance across global sites and partners.
Responsibilities
- Lead operational planning and execution for late-phase global clinical trials
- Develop and manage clinical study timelines and key milestones
- Oversee selection and performance of clinical trial vendors and CROs
- Ensure adherence to regulatory requirements and company standards
- Collaborate with cross-functional teams including regulatory, data management, and safety
- Monitor study progress and implement risk mitigation strategies
- Manage budget forecasting and financial oversight for assigned studies
- Support development of clinical operations strategies for pipeline programs
- Lead preparation for study initiation, conduct, and close-out activities
- Ensure data quality and integrity across clinical trial systems
- Drive process improvements in clinical operations workflows
- Serve as primary point of contact for operational issues within clinical teams
- Provide input into protocol design from an operational feasibility perspective
- Coordinate global team alignment on study execution plans
- Oversee clinical supply logistics and site support systems
- Ensure compliance with ICH-GCP and applicable regulatory guidelines
- Lead operational aspects of health authority inspections and audits
- Support training and knowledge transfer across clinical operations staff
- Evaluate new technologies and tools to enhance trial efficiency
- Contribute to internal process standardization and best practices
- Manage vendor contracts and service level agreements
- Facilitate governance committee meetings and reporting
- Ensure timely delivery of clinical trial deliverables
- Promote patient-centric approaches in trial design and execution
- Support regional and global team collaboration across time zones
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model with flexibility based on role and location
Team
Part of a global clinical development team focused on advancing novel therapies
Why Join Us
- Be part of a patient-focused organization committed to transforming the standard of care in severe autoimmune and rare diseases
- Work in a dynamic, science-driven environment that values innovation and collaboration
- Opportunity to shape the future of clinical development in a high-growth company
Our Commitment to Diversity and Inclusion
- We believe diverse perspectives drive better science and stronger teams
- We foster an inclusive culture where all voices are valued and respected
- Equal opportunity is central to our hiring and development practices
Available for qualified candidates where permitted by local regulations
