Director, Drug Safety
About The Position
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. 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 interactions.
Requirements
- 8+ years of experience in biopharmaceutical drug safety and/or pharmacovigilance, including experience in a safety leadership capacity.
- Degree in a life science or related discipline preferred (e.g., PharmD, MD, BSN or related field)
- Experience in oncology and/or neurology, neurodegenerative, or rare disease development.
- Experience leading or supporting safety strategy through late-stage clinical development and registration-enabling programs.
- Experience supporting or leading safety-related regulatory interactions, including development of briefing materials, responses, and other regulatory content.
- Strong working knowledge of global pharmacovigilance requirements, including FAERS, EudraVigilance, and applicable ICH E2 guidelines.
- Working knowledge of MedDRA and WHO Drug dictionaries.
- Experience with safety databases and signal detection tools, such as Argus or ArisGlobal.
- Experience supporting health authority inspections and pharmacovigilance audits
- Excellent scientific writing, communication, and presentation skills, with the ability to translate complex safety data into clear recommendations for technical and executive audiences.
- Demonstrated ability to influence cross-functional teams, build alignment among diverse stakeholders, and drive decision-making without direct authority.
- Experience operating independently in a lean biotechnology environment, balancing scientific, safety, regulatory, operational, and benefit-risk considerations.
Nice To Haves
- Demonstrated ownership of safety strategy for a US marketing application (NDA or BLA) or major US/EU regulatory submission.
- Strong scientific judgment and the ability to develop and adapt safety strategy in situations where precedent is limited, evolving, or subject to interpretation.
- Experience with expedited development programs, such as Fast Track, Breakthrough Therapy, orphan drug designation, accelerated approval, or PRIME.
- Experience with REMS or other risk minimization program design and implementation.
- Comfort with emerging technologies and innovative approaches to improve safety surveillance, data review, and operational efficiency while maintaining scientific and regulatory rigor.
Responsibilities
- 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.
- Support Data Safety Monitoring Board (DSMB) activities and provide safety input into protocols, investigator brochures, clinical study reports, and other key clinical and regulatory documents.
- Represent Drug Safety on cross-functional program teams and governance forums, translating complex safety data and emerging risks into clear, actionable recommendations for program leadership and executive management.
- Provide Drug Safety leadership to support commercial planning and launch activities.
- Build and maintain core safety infrastructure, processes, vendor oversight standards, and SOPs in alignment with applicable regulations and ICH guidelines.
- Operate as a hands-on leader within a lean, cross-functional organization; no direct reports at hire, with the opportunity to build the function over time.
Benefits
- Medical, dental, and vision coverage: Leona covers 100% of employee premiums and 80% of dependent premiums (Premera Blue Cross PPO, Delta Dental, VSP)
- 401(k) with employer match: immediate eligibility, with Leona matching 100% of employee contributions up to 4% of salary
- Generous PTO: 25 days accrued annually, plus 11 paid holidays and a company-wide closure the last week of December
- Life & disability coverage: Basic Life, AD&D, Short-Term and Long-Term Disability fully paid by Leona, with voluntary options available
- Flexible Spending Accounts: Health and Dependent Care FSA options
- Professional development: up to $6,000 annually reimbursed for job-relevant, manager-approved education
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Associate degree
