Senior Director, Global Clinical Safety & Risk Management

Daiichi Sankyo US; Basking Ridge (NJ); Sur place; USD 280 000 - 467 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Leadership

Safety analysis

Formation

MD Board certification or eligibility

Description du poste

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.