Director, Safety Sciences — Lead Global Pharmacovigilance & Strategy

Olema Oncology; Boston (MA); Híbrido; USD 235 000 - 255 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Equity

Bonus

Comprehensive benefits

Resumo da oferta

Scorpion Therapeutics is looking for a Director of Safety Sciences in Boston or San Francisco. This role encompasses leading safety strategy across product development, managing regulatory submissions, and fostering cross-functional collaboration.

The ideal candidate will have extensive experience in pharmacovigilance, strong oncology knowledge, and be adept in regulatory interactions and compliance. Compensation ranges from $235,000 to $255,000, with added equity and benefits.

Qualificações

• 8+ years pharmacovigilance/drug safety experience (MD/PhD/PharmD) or 10+ years (RN).
• Experience in late-phase clinical development and NDA/BLA submissions.
• Strong knowledge of FDA/EU/ICH pharmacovigilance regulations.

Responsabilidades

• Lead strategy and communication of clinical safety data throughout development.
• Oversee NDA/BLA safety deliverables and benefit-risk assessments.
• Prepare/review safety documents and regulatory application materials.

Conhecimentos

Pharmacovigilance

Oncology

Communication

Analytical skills

Strategic planning

Formação académica

MD/PhD or PharmD or RN

Ferramentas

CTD/eCTD

Clinical database/EDC

Safety database queries

Descrição da oferta de emprego

Scorpion Therapeutics is looking for a Director of Safety Sciences in Boston or San Francisco. This role encompasses leading safety strategy across product development, managing regulatory submissions, and fostering cross-functional collaboration.

The ideal candidate will have extensive experience in pharmacovigilance, strong oncology knowledge, and be adept in regulatory interactions and compliance. Compensation ranges from $235,000 to $255,000, with added equity and benefits.