Clinical Trials Director
4 days ago
About Daiichi Sankyo, Inc.
Daiichi Sankyo Group is a global pharmaceutical innovator dedicated to improving standards of care and addressing unmet medical needs. With over 125 years of scientific expertise, we have a rich legacy of innovation and a robust pipeline of promising new medicines.
Job Summary:
The Clinical Trials Director will provide strategic direction and planning for clinical trial execution, ensuring regulatory compliance and cross-functional cohesiveness. This role involves overseeing the development of SOPs, maintaining awareness of updates, and coordinating implementation across functions.
Responsibilities:
- Develop and maintain an overview of Development SOP landscape, including planned new documents, changes, and retirements.
- Create awareness of SOP updates resulting from organizational changes, regulatory requirements, CAPAs, cross-functional initiatives, and routine process updates.
- Identify, escalate, and plan mitigations related to potential systemic gaps in the Development SOP landscape and/or processes.
- Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee.
Requirements:
- Bachelor's Degree with at least 10 years of experience in pharmaceutical or biotechnology development functions or clinical quality assurance.
- Strong understanding of GCPs and applicable global regulatory guidelines governing clinical trials preferred.
- Experience with end-to-end clinical trial processes and functions, including one or more Development functions preferred.
Salary: $120,000 - $160,000 per year
About the Role:
This is a critical position that requires strong leadership and project management skills, as well as the ability to influence others without direct authority. The ideal candidate will have experience working with Quality Management systems, process improvement methodologies, and global health authority inspections.
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