Director, Safety Sciences

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

Director, Safety Sciences

Responsibilities

• Lead strategy, evaluation, and communication of clinical safety data across the development lifecycle to support global regulatory submissions and product development.
• Oversee key safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments and cross-functional alignment on safety strategy and regulatory interactions.
• Author/review integrated safety documents (ISS, SCS, benefit-risk assessments, clinical overviews) and develop submission-ready safety narratives, datasets, analyses, and clinical safety evaluations.
• Prepare/review safety sections of regulatory documents (NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, CCDS).
• Lead development/maintenance of RMPs, REMS, and other risk management documents.
• Support health authority meetings; partner with QA for inspections/audits.
• Review safety findings for regulatory decision-making and labeling recommendations; contribute to product labeling.
• Oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs, periodic safety reports) and provide regulatory risk mitigation input.

Qualifications / Skills

• MD/PhD (medical/biological science), PharmD, or RN.
• Small molecule and oncology experience required.
• 8+ years (MD/PhD/PharmD) or 10+ years (RN) pharmacovigilance/drug safety in biopharma.
• Late-phase development/registration experience; NDA/BLA submission readiness planning.
• Experience integrating clinical safety data; ISS authoring/review; benefit-risk assessments; safety labeling strategy.
• Ability to apply FDA/EU/ICH pharmacovigilance guidance; CTD/eCTD and clinical database/EDC knowledge.
• Strong written/verbal communication, analytical/problem-solving, strategic planning, and ethical judgment.

Compensation

Base pay range: $235,000–$255,000 annually; total compensation includes equity, bonus, and benefits.