Sr. Manager / Associate Director, Trial Master File (TMF) Operations Lead

Job Description

• ML Bio Solutions is searching for an experienced TMF Operations Lead to shape the critical role for ensuring completeness and accuracy of the TMF for all BBP-418 clinical trials. This individual is responsible for providing expert guidance in TMF management, driving a culture of compliance and quality that aligns with ICH/GCP guidelines, regulatory requirements, and internal policies. Reporting to the Head of Global Clinical Operations, the TMF Operations Lead will be a member of all Study Execution Teams, reporting and assessing study activities and independently translating them into requirements for the TMF. Will act as Subject Matter Expert lead for innovation projects to enhance TMF quality assessment.

Qualifications

• 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 5 years extensive experience in similar roles and proven track record; direct industry experience in lieu of education will be considered • 6-8 years of overall relevant clinical operations and TMF experience at a biotechnology, pharmaceutical, or TMF vendor • Understanding of the clinical trial lifecycle • 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 possesses 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 • Travel - Remote candidates must be willing to travel for company meetings a minimum of one week per quarter; travel for team and/or study meetings may be required • Role level will be filled commensurate with experience

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak • An unyielding commitment to always putting patients first. Learn more about how we do this here • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science • A place where you own the vision – both for your program and your own career path • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game • Access to learning and development resources to help you get in the best professional shape of your life • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) • Flexible PTO • Rapid career advancement for strong performers • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time • Partnerships with leading institutions • Commitment to Diversity, Equity & Inclusion