Global Oncology Medical Affairs Leader

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 272,000 - 453,000; Full time

Job summary

Daiichi Sankyo US is seeking a seasoned leader to head Global Clinical Operations, guiding clinical staff and ensuring GCP/SOP compliance while coordinating CIS, NIS, EAP, IIS, and ECSR programs across regions including the US, Europe, ASCA, and Japan.

You will drive study budgets, timelines, and quality metrics, partner with regional teams, and mentor project managers to optimize trial execution and regulatory submissions in partnership with GMAT and cross-functional groups.

Qualifications

• Bachelor's degree required; life science/healthcare preferred.
• Advanced degree preferred.
• 10+ years of related experience.
• 4+ years in pharmaceutical clinical research.
• 4+ years in people management in a global/matrix environment.
• Strong leadership and problem-solving skills; knowledge of clinical development and GCP.
• Willingness to travel up to 20%.

Responsibilities

• Lead Global Clinical Operations Study/Program Management for CIS, NIS, EAP across regions.
• Provide strategic input into protocols, CRFs and monitoring plans; ensure timelines and budgets.
• Ensure accuracy and timeliness of information in databases and tracking systems.
• Coordinate with regulatory and cross-functional stakeholders across regions (US, Europe, ASCA, Japan).
• Oversee IIS and ECSR processes, and ensure SOP compliance.
• Develop and manage annual objectives, budgets, contracts, and vendor relationships.
• Collaborate with regional teams to ensure alignment and operational excellence in medical affairs trial activities.

Skills

Leadership

Budget management

Project management

Cross-functional collaboration

GCP knowledge

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

CTMS

Data management systems

Job description

Daiichi Sankyo US is seeking a seasoned leader to head Global Clinical Operations, guiding clinical staff and ensuring GCP/SOP compliance while coordinating CIS, NIS, EAP, IIS, and ECSR programs across regions including the US, Europe, ASCA, and Japan.

You will drive study budgets, timelines, and quality metrics, partner with regional teams, and mentor project managers to optimize trial execution and regulatory submissions in partnership with GMAT and cross-functional groups.