Director, Drug Safety

🕒 Setembro 1

☕ Washington – Remoto

☕ Washington – Remote

💵 $220.000 - $250.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 4%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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LeonaBio

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

🏥 Saúde

💰 $103.500.000 Post IPO equity em 2021-02

Biotechnology • Pharmaceuticals • Healthcare

A LeonaBio é uma empresa biofarmacêutica em estágio clínico que se concentra no desenvolvimento de novas terapias de pequenas moléculas para doenças graves com opções de tratamento limitadas. Seus principais candidatos incluem o lasofoxifeno e o brelgometon (ATH-1105), e a empresa realiza ensaios clínicos para avaliar a segurança e eficácia como parte de sua missão de melhorar o cuidado ao paciente. A LeonaBio está ativa em assuntos médicos e engajamento de pacientes e recentemente apresentou o ATH-1105 em um congresso de desenvolvimento de medicamentos para ELA, indicando envolvimento na pesquisa de doenças neurodegenerativas.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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