# Director, Drug Safety at LeonaBio

- Company: LeonaBio
- What the company does: Backed by NEA.
- Company website: https://leonabio.com/
- Type: Startups
- Level: Principal and up
- Location: Remote (US)
- Work setup: Remote
- Pay: $220K to $250K base salary per year (USD)
- Posted: 2026-09-01
- Apply by: 2026-10-16
- Apply: https://leonabio.bamboohr.com/careers/80
- Page: https://www.1752.vc/careers/jobs/leonabio-director-drug-safety/

## About the role

LeonaBio is seeking a Director, Drug Safety to lead drug safety and pharmacovigilance strategy across two development programs in early and late stages of development. Reporting to the SVP, Drug Development Operations, this is a hands-on leadership role with the opportunity to build core safety infrastructure within a lean biotech environment.

## What they're looking for

- Own global drug safety and pharmacovigilance strategy across two development programs, aligning safety activities with clinical, regulatory, and CMC milestones and commercial planning
- Lead signal detection, evaluation, safety surveillance, and risk management activities, developing clear benefit-risk assessments and appropriate risk mitigation strategies
- Serve as the safety lead for health authority interactions, including FDA meetings and other regulatory engagements, develop safety briefing materials, responses, and related content
- Lead/contribute to dossier development for marketing authorizations including Integrated Summary of Safety (ISS) development, safety narratives, labeling, and submission-level safety content
- Oversee aggregate safety reporting, including DSURs, PSURs/PBRERs, and other periodic safety reports, ensuring timely and high-quality submissions
- , assessment, reconciliation, and regulatory reporting across applicable health authorities