About This Role
Leading strategic and operational efforts for neuroscience clinical development programs is the core of this Director of Clinical Operations role. The position involves providing leadership in planning, execution, and oversight of global clinical trials with scientific rigor and operational excellence, while collaborating with cross-functional teams to ensure alignment with clinical development objectives and regulatory requirements.
Responsibilities
- Lead strategic and operational efforts for neuroscience clinical development programs
- Provide leadership in planning, execution, and oversight of global clinical trials with scientific rigor and operational excellence
- Collaborate with cross-functional teams to ensure alignment with clinical development objectives and regulatory requirements
- Lead and develop a high-performing team, fostering innovation and continuous improvement in clinical trial execution
- Ensure effective oversight of clinical sites, CROs, and vendors to maintain quality and accountability
- Drive operational metrics, KPIs, and performance reporting to support program success
- Represent Clinical Operations in governance forums, providing updates on program status and risk mitigation strategies
- Support inspection readiness and compliance initiatives to ensure adherence to global regulations
- Define and implement clinical operations strategies, including study design, timelines, budgets, and risk mitigation
- Monitor operational metrics and drive continuous improvement initiatives
- Identify opportunities for innovation and process improvements in clinical trial execution
Requirements
- Bachelor's degree in science or related field; advanced degree preferred
- Minimum 10 years of experience in clinical operations within the pharmaceutical or biotechnology industry
- Proven expertise in neuroscience, CNS, psychiatry, or neurodegenerative diseases
- Experience managing global clinical trials across all phases (I-IV)
- Strong leadership skills with a focus on team development and operational excellence
- Advanced knowledge of ICH/GCP and applicable global regulations
- Proficiency in clinical trial strategy, budget management, and vendor oversight
- Excellent communication and problem-solving skills, with ability to influence senior leaders
- Experience supporting regulatory inspections and implementing quality initiatives
About the Company
This company is in the pharmaceuticals industry.