Executive Director, Clinical Operations - Neurodegeneration
New
US, eastern time zone strongly preferred., North America, Europe, Israel time zonesFull-TimeExecutive
Salary not disclosed
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Job Details
- Experience
- Minimum 10 to 15 years
- Required Skills
- Data AnalysisGCPMicrosoft Office
Requirements
- Bachelor’s degree or higher in Life Sciences or related field
- Minimum 10 to 15 years of clinical operations management experience in biotech companies
- At least 5 years leading global phase 3 studies and cross-functional teams
- Recent experience in leading the conduct of global phase 3 studies from start to completion
- Experience with rare disease required
- Experience with ALS or HD highly preferred
- Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices (GCP), ICH and applicable Standard Operating Procedures
- Strong strategic thinking and project management skills
- Expertise in patient recruitment and retention strategies at a global scale
- Strong leadership skills and advanced stakeholder management and communication skills
- Demonstrated ability to manage CROs (and other vendors) to meet or exceed KPIs
- Proficiency with clinical research technologies and platforms (EDC, eTMF, IWRS, CTMS, etc.)
- Strong skills in Microsoft Office and data analysis tools
- Willingness and ability to travel (domestic & international) up to 30%
Responsibilities
- Provide strategic direction and operational leadership for pivotal global clinical programs
- Lead clinical operations aspects of clinical programs, including planning, coordination, delegation, communication and stepping into direct action as necessary
- Accountable for the successful delivery and inspection readiness of complex global pivotal trial/s; own operational timelines, budget management, enrollment performance, data quality, and risk mitigation
- Lead clinical study team/s including both internal and external stakeholders, fostering accountability, collaboration and operational excellence
- Develop and oversee effective and efficient clinical study plans in partnership with internal and external stakeholders
- Oversee site and investigator relationships, leading the implementation of innovative patient recruitment and retention strategies
- Ensure clinical monitoring quality and ongoing adherence to established study plans and GCP requirements
- Closely collaborate with Regulatory, Quality, Safety, Data management and clinical supply to integrate cross-functional insights into operational execution
- Build and sustain strong cross-functional relationships across diverse global teams
- Communicate progress, risks, and strategic insights to executive leadership and governance committees
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