Backed by NEA.
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
More about this role
About Leona
LeonaBio, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company developing novel therapeutics for high unmet medical needs, including treatment-resistant metastatic breast cancer and amyotrophic lateral sclerosis (ALS). Our lead programs, lasofoxifene and brelgometon, are novel small-molecule therapies with the potential to address devastating diseases where current treatment options are limited or ineffective. We are committed to scientific excellence and patient-centered innovation as we advance meaningful new therapies for patients.
Position Summary
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. The Director will serve as a key cross-functional and executive partner, providing strategic safety guidance, leading signal detection and risk management activities, and supporting regulatory submissions and health authority...
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