Senior Director, Global Clinical Safety & Risk Management

Daiichi Sankyo US; Basking Ridge (NJ); Vor Ort; USD 280.000 - 467.000; Vollzeit

Zusammenfassung

Daiichi Sankyo US seeks a Sr. Director, Clinical Safety to lead integrated risk management strategies for Development Sankyo’s compounds, coordinating with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other groups to optimize benefit-risk from discovery through commercialization.

The role requires strong leadership to guide physicians and scientists, review trial and post-marketing data for safety signals, and lead safety-related regulatory interactions.

Qualifikationen

• MD Board certification or eligibility required.
• 6+ years of experience in the pharmaceutical industry, regulatory agency or academia with exposure to drug development, clinical pharmacology, and/or epidemiology.
• Experience in clinical development, submission and post marketing is strongly recommended.

Aufgaben

• Lead and medically-direct a team of physicians and scientists across development stages.
• Represent CSPV on Global Product Team and cross-functional groups for safety leadership.
• Identify safety signals from clinical trials and post-marketing data and manage risk.
• Define and implement risk management strategies across the product lifecycle and ensure timely safety deliverables.

Kenntnisse

Leadership

Safety analysis

Ausbildung

MD Board certification or eligibility

Jobbeschreibung

Daiichi Sankyo US seeks a Sr. Director, Clinical Safety to lead integrated risk management strategies for Development Sankyo’s compounds, coordinating with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other groups to optimize benefit-risk from discovery through commercialization.

The role requires strong leadership to guide physicians and scientists, review trial and post-marketing data for safety signals, and lead safety-related regulatory interactions.