Director, Drug Safety

Job not on LinkedIn

🔥 0 minutes ago

☕ Washington – Remote

☕ Washington – Remote

💵 $220k - $250k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

LeonaBio

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $103.5M Post IPO equity on 2021-02

Biotechnology • Pharmaceuticals • Healthcare

LeonaBio is a clinical-stage biopharmaceutical company focused on developing novel small-molecule therapies for serious diseases with limited treatment options. Its lead candidates include lasofoxifene and brelgometon (ATH-1105), and the company conducts clinical trials to evaluate safety and efficacy as part of its mission to improve patient care. LeonaBio is active in medical affairs and patient outreach and has recently presented ATH-1105 at an ALS drug development summit, indicating involvement in neurodegenerative disease research.

📋 Description

• 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 • Develop clear benefit-risk assessments and appropriate risk mitigation strategies • Serve as safety lead for health authority interactions, including FDA meetings and other regulatory engagements • Develop safety briefing materials, responses, and related content • Lead or contribute to dossier development for marketing authorizations, including ISS development, safety narratives, labeling, and submission-level safety content • Oversee aggregate safety reporting, including DSURs, PSURs/PBRERs, and other periodic safety reports • Lead safety case assessment, reconciliation, and regulatory reporting across applicable health authorities • Support DSMB activities and provide safety input into protocols, investigator brochures, clinical study reports, and other clinical and regulatory documents • Represent Drug Safety on cross-functional program teams and governance forums • Translate 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 opportunity to build the function over time

🎯 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 • Preferred: demonstrated ownership of safety strategy for a US marketing application (NDA or BLA) or major US/EU regulatory submission • Preferred: strong scientific judgment and ability to develop and adapt safety strategy where precedent is limited, evolving, or subject to interpretation • Preferred: experience with expedited development programs, such as Fast Track, Breakthrough Therapy, orphan drug designation, accelerated approval, or PRIME • Preferred: experience with REMS or other risk minimization program design and implementation • Preferred: comfort with emerging technologies and innovative approaches to improve safety surveillance, data review, and operational efficiency while maintaining scientific and regulatory rigor

🏖️ 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 • 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 • Annual bonus eligibility • Equity eligibility • Full benefits package