Director, Safety Sciences

Olema Oncology; Boston (MA); On-site; USD 235,000 - 255,000; Full time

Benefits offered by this job

Equity

Bonus

Comprehensive benefits

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Pharmacovigilance

Oncology

Communication

Analytical skills

Strategic planning

Education

MD/PhD or PharmD or RN

Tools

CTD/eCTD

Clinical database/EDC

Safety database queries

Job description

Director, Safety Sciences

Responsibilities

• Lead strategy, evaluation, and communication of clinical safety data across the development lifecycle, supporting global regulatory submissions and product development.
• Oversee safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments; drive cross-functional alignment on safety strategy and regulatory interactions.
• Author/review integrated safety documents (ISS, SCS), benefit-risk assessments, and clinical overviews; develop safety narratives, datasets, analyses, and submission-ready deliverables.
• Evaluate and integrate safety data to support benefit-risk for marketing applications.
• Collaborate with Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, and Programming to develop safety strategies/analyses.
• Prepare/review safety sections of regulatory documents (NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, CCDS).
• Lead Risk Management Plans (RMPs), REMS, and other risk management documents; participate in health authority meetings and respond to questions.
• Partner with QA for inspections/audits; review safety findings from clinical/literature/post‑marketing data to support regulatory decisions and labeling.
• Contribute to product labeling safety sections and oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs).

Qualifications

• MD/PhD (medical/biological science), PharmD, or RN; Small Molecule and Oncology required.
• 8+ years (MD/PhD/PharmD) or 10+ years (RN) pharmacovigilance/drug safety experience in biopharma.
• Late‑phase clinical development/registration; NDA/BLA submission readiness; ISS authoring/review.
• Proven benefit‑risk and regulatory justification; labeling strategy/negotiations; experience preparing for health authority meetings.
• Working knowledge of FDA/EU/ICH pharmacovigilance; CTD/eCTD; clinical database/EDC; safety database queries.
• Manage/mentor junior team; lead safety vendor management; contribute to process improvements.

Attributes

• Strong communication, analytical/problem‑solving, strategic planning; time management; ethical judgment; fast learner.

Application / Location

Based in San Francisco or Boston; <10% travel.

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