Director, Safety Sciences — Regulatory Strategy & Risk (Equity)

Scorpion Therapeutics; San Francisco (CA); On-site; USD 235,000 - 255,000; Full time

Job summary

Scorpion Therapeutics is seeking a Director of Safety Sciences in San Francisco to lead clinical safety strategy and oversee regulatory submissions. The ideal candidate will have extensive experience in pharmacovigilance, particularly in small molecules and oncology.

With 8+ years of relevant experience for MD/PhD/PharmD or 10+ years for RN, the candidate should be adept at managing safety data and preparing key regulatory documents. A competitive salary range of $235,000–$255,000 annually is offered, along with equity and bonuses.

Qualifications

• 8+ years experience in pharmacovigilance/drug safety for MD/PhD/PharmD, or 10+ years for RN.
• Experience integrating clinical safety data and authoring safety documents.
• Knowledge of CTD/eCTD and clinical database/EDC.

Responsibilities

• Lead strategy for clinical safety data across development lifecycle.
• Oversee NDA/BLA filings and benefit-risk assessments.
• Prepare safety sections of regulatory documents and develop safety narratives.
• Review safety findings for regulatory decision-making.

Skills

Small molecule and oncology experience

Pharmacovigilance/drug safety

FDA/EU/ICH pharmacovigilance guidance

Strong written/verbal communication

Analytical/problem-solving skills

Strategic planning

Ethical judgment

Education

MD/PhD, PharmD, or RN

Job description

Scorpion Therapeutics is seeking a Director of Safety Sciences in San Francisco to lead clinical safety strategy and oversee regulatory submissions. The ideal candidate will have extensive experience in pharmacovigilance, particularly in small molecules and oncology.

With 8+ years of relevant experience for MD/PhD/PharmD or 10+ years for RN, the candidate should be adept at managing safety data and preparing key regulatory documents. A competitive salary range of $235,000–$255,000 annually is offered, along with equity and bonuses.