Global Oncology Governance Lead

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 127,000 - 191,000; Full time

Job summary

Daiichi Sankyo is seeking an experienced GOMA Governance Office Manager to lead evidence generation governance for company-funded studies, EAPs, and related functions. You will oversee review committee operations and ensure regulatory alignment with GDP and GSOPs.

You will collaborate with Global Oncology Medical Affairs and cross‑functional teams to drive timely decisions, improve data integrity, and maintain robust documentation and KPI reporting.

Qualifications

• GCP knowledge and regulatory awareness required.
• Experience with clinical study governance and oversight.
• Ability to interpret SOPs and translate into actionable governance actions.

Responsibilities

• Lead governance framework maintenance and implementation for global oncology review processes.
• Ensure GSOP adherence and track milestones across regional/global reviews.
• Oversee data integrity and documentation practices (GDP) across committee activities.
• Track KPI trends and ensure timely and compliant decision-making.
• Collaborate with Global Oncology Medical Affairs and cross-functional teams to support governance.

Skills

GCP knowledge

ICH guidelines

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's Degree

Job description

Daiichi Sankyo is seeking an experienced GOMA Governance Office Manager to lead evidence generation governance for company-funded studies, EAPs, and related functions. You will oversee review committee operations and ensure regulatory alignment with GDP and GSOPs.

You will collaborate with Global Oncology Medical Affairs and cross‑functional teams to drive timely decisions, improve data integrity, and maintain robust documentation and KPI reporting.