Associate Director, TMF Operations Lead

🕒 il y a 13 jours

🇺🇸 États-Unis – Télétravail

💵 $191 000 - $220 000 / an

⏰ Temps Plein

🟠 Senior

⚙️ Opérations

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BridgeBio

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 2015

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

BridgeBio est une entreprise de biotechnologie qui se concentre sur la conception de médicaments transformateurs pour les patients atteints de maladies génétiques. Elle utilise une approche novatrice du développement de médicaments en intégrant la finance avec la science pour fournir des solutions aussi efficacement que possible. L'entreprise s'engage à développer non seulement des médicaments qui changent la vie, mais également des leaders dans le domaine, en encourageant l'engagement pratique et la quête d'innovation. BridgeBio recherche activement des investissements pour aider à réaliser sa mission de fournir des solutions pour des populations de patients uniques avec des besoins non satisfaits. Basée à Palo Alto, en Californie, BridgeBio met l'accent sur le rapprochement entre les avancées scientifiques et les soins aux patients.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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