Director, Drug Safety

LeonaBio, Inc.; Bothell (WA); On-site; USD 220,000 - 250,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with employer match

PTO: 25 days + 11 holidays

Life & disability coverage

FSA options

Professional development up to $6,000

Job summary

LeonaBio, Inc. in the Seattle area seeks a Director of Drug Safety to lead pharmacovigilance strategy across two development programs, guiding safety data, risk management, and regulatory interactions.

This hands-on leadership role builds core safety infrastructure in a lean biotech setting. You will oversee signal detection, DSURs, PSURs, and ISS development, collaborate with clinical, regulatory, and CMC teams, and serve as safety lead for FDA engagements, while mentoring future safety

Qualifications

• 8+ years of biopharmaceutical drug safety/pharmacovigilance experience in leadership roles.
• Degree in life science or related discipline preferred (e.g., PharmD, MD, BSN).
• Experience in oncology and/or neurology, or neurodegenerative/rare disease development.
• Experience leading safety strategy through late-stage development and registration.
• Experience supporting safety regulatory interactions, including briefing materials and responses.
• Strong knowledge of global pharmacovigilance requirements (FAERS, EudraVigilance, ICH E2).

Responsibilities

• Own global drug safety and pharmacovigilance strategy across two programs, aligning with milestones.
• Lead signal detection, safety surveillance, and risk management activities with clear benefit-risk assessments.
• Serve as safety lead for health authority interactions (FDA and others) and develop safety briefing materials.
• Lead/contribute to dossier development for marketing authorizations and ISS.
• Oversee aggregate safety reporting (DSURs, PSURs/PBRERs) and other periodic safety reports.
• Support DSMB activities and safety input into protocols and clinical study reports.
• Represent Drug Safety in cross-functional teams and translate safety data into actionable recommendations.
• Provide Drug Safety leadership to support commercial planning and launches.
• Build core safety infrastructure, vendor oversight standards, and SOPs in line with ICH.

Skills

Strategic safety leadership

Cross-functional collaboration

Medical writing

Regulatory submissions

Signal detection

Risk management

Stakeholder communication

Education

PharmD/MD/BSN or related

Oncology/Neurology or related field experience

Tools

Argus/ArisGlobal

MedDRA/WHO dictionaries

Job description

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 interactions.

Key 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.
• , assessment, reconciliation, and regulatory reporting across applicable health authorities.
• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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. (soften a bit)
• 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.

Benefits & Perks

We offer a comprehensive benefits package designed to support our employees and their families, including:

• 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

Compensation

The base salary range for this position is $220,000-$250,000. This role may be eligible for an annual bonus and equity, in addition to our full benefits package outlined above. Actual compensation will be determined based on factors including relevant experience, skill set, education, and internal pay equity.

LeonaBio is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination.