Associate Director, TMF Operations Lead

🕒 Julho 24

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $191.000 - $220.000 / ano

⏰ Tempo Integral

🟠 Sênior

⚙️ Operações

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BridgeBio

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2015

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A BridgeBio é uma empresa de biotecnologia focada em projetar medicamentos transformadores para pacientes com doenças genéticas. Ela emprega uma abordagem inovadora para o desenvolvimento de medicamentos, integrando finanças à ciência para oferecer soluções da forma mais eficiente possível. A empresa está comprometida em desenvolver não só medicamentos que mudam vidas, mas também líderes na área, incentivando o envolvimento prático e a busca por inovação. A BridgeBio busca ativamente investimentos para ajudar a alcançar sua missão de fornecer soluções para populações de pacientes únicas com necessidades não atendidas. Com sede em Palo Alto, CA, a BridgeBio enfatiza a conexão entre avanços científicos e cuidados com o paciente.

Descrição

• Lead TMF operations across assigned clinical studies, ensuring timely, complete, and inspection-ready Trial Master File documentation in compliance with ICH-GCP, regulatory requirements, and company standards. • Establish TMF governance across the clinical development program by monitoring TMF health, quality metrics, risk assessments, and inspection readiness, and communicating key findings to study teams and leadership. • Develop, maintain, and continuously improve TMF processes and governing documents, including TMF Plans, TMF Indexes, SOPs, guidance documents, and CRO TMF Oversight Plans. • Partner with Clinical Operations, Regulatory, Data Management, Medical Writing, Quality Assurance, and external vendors to ensure timely document filing, issue resolution, and consistent execution of TMF processes. • Provide strategic oversight of CRO-managed TMF activities through performance metrics, governance meetings, quality reviews, issue escalation, and continuous improvement initiatives. • Lead TMF inspection readiness activities, including ongoing quality reviews, health assessments, audit support, inspection preparation, artifact retrieval, and CAPA development and follow-up. • Identify TMF compliance risks and quality trends, develop mitigation strategies, and drive corrective and preventive actions to maintain a state of continuous inspection readiness. • Serve as the TMF Subject Matter Expert by providing strategic guidance, delivering training, mentoring study teams, and representing TMF Operations on cross-functional initiatives. • Analyze TMF performance metrics and vendor quality outputs to identify trends, recommend process improvements, and strengthen operational effectiveness across the development program. • Foster a culture of TMF excellence through knowledge sharing, lessons learned, and implementation of innovative approaches to improve TMF quality and efficiency

🎯 Requisitos

• Minimum Education requirement: University degree qualified or comparable professional education, preferably in medicine / science, paramedical science, computer science, business management or related degree or more than 8 years extensive experience in similar roles and proven track record; direct industry experience in lieu of education will be considered • 8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality, including experience supporting global clinical trials • Understanding of the drug development life cycle • Experience in handling clinical trial-related documents required • Strong knowledge of Trial Master File Reference Model Structure standard and country-level documents • Demonstrated ability to understand and comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices • Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment • Excellent organizational skills and possess high standards and great attention to detail • Strong communication skills – verbal and written • Highly conscientious and takes initiative to efficiently resolve issues • Must be resourceful and adaptable to support multiple competing demands and changing priorities • Proven successes in problem-solving, strong decision-making, critical thinking, and conflict management • Must be proficient in Microsoft Excel, Word, and PowerPoint, and familiar with Smartsheet and SharePoint

🏖️ Benefícios

• Market-leading compensation • 401(k) with employer match • Employee Stock Purchase Program (ESPP) • Pre-tax commuter benefits (transit and parking) • Referral bonus for hired candidates • Subsidized lunch and parking on in-office days • 100% employer-paid medical, dental, and vision premiums for you and your dependents • Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA) • Fertility & family-forming benefits • Expanded mental health support (therapy and coaching resources) • Hybrid work model with flexibility • Flexible, “take-what-you-need” paid time off and company-paid holidays • Comprehensive paid medical and parental leave to care for yourself and your family