Global Oncology Governance Leader - Medical Affairs

Daiichi Sankyo, Inc.

Basking Ridge (NJ)

On-site

USD 127,000 - 191,000

Full time

4 days ago

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Job summary

Daiichi Sankyo, Inc. is seeking a GOMA Governance Review Committee Office Manager to lead evidence generation governance, ensure regulatory compliance, and oversee global oncology review processes across studies and expanded access programs.

You will partner with Global Oncology Medical Affairs and cross-functional teams to drive timely, compliant decision-making and governance. The role emphasizes data integrity, GDP adherence, and lifecycle milestone tracking, with a focus on continuous

Qualifications

Bachelor's degree required.
4+ years in clinical development operations or governance.
Experience leading review committee management and regulatory compliance.
Strong analytical and stakeholder management skills.

Responsibilities

Governance Oversight: Maintain governance frameworks and ensure oversight of global oncology review processes for studies and programs.
Operational Leadership: Drive timelines, KPIs, and GDP-compliant documentation and data integrity across systems.
Collaboration & Stakeholder Engagement: Liaise with regional teams and Global Medical Affairs for aligned activities.
Process Improvement & Compliance: Lead process standard improvements and CAPA actions where needed.
Systems & Data Management: Oversee data systems, lifecycle milestones, and training for teams.
Quality Assurance & Regulatory Management: Support audits, inspections, and quality events with cross-functional teams.