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

ML Bio Solutions Remote - United States Clinical Operations

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About MLBio Solutions & BridgeBio Pharma

ML Bio Solutions (ML Bio), a BridgeBio company, is a biotechnology company founded in 2018, yet the company’s founders have been dedicated to finding a cure for Limb girdle muscular dystrophy type 2I/R9 FKRP-related (LGMD2I/LGMDR9) for close to twenty years. ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas, including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.  
 
Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 
 
To learn more about our story and company culture, visit us at https://mlbiosolutions.com/ | https://bridgebio.com

Who You Are

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.

Responsibilities

  • Day-to-day management of TMF files for their respective studies, including the upload, review, and approval of TMF documents
  • Co-authors and manages TMF documents such as TMF Plan, Index, SOPs, and other guidance documents
  • Ensuring quality management of their studies by reporting TMF metrics, periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues, e.g. CAPAs
  • Collaborate with GCP Quality Assurance in high-level projects, developing processes and strategies and conducting training for TMF stakeholders
  • Partner with Clinical Operations to ensure timely, consistent, and quality setup and maintenance of TMF requirements and processes, including user access, document QC, upload, remediation, and query management
  • Develop successful working relationships with internal and external TMF stakeholders
  • Serves as Subject Matter Expert on TMF training materials, formal and informal processes, and tracking tools for TMF oversight activities
  • Partner with study teams to conduct quality checks of the TMF for inspection readiness with the goal of compliance with regulations and global harmonization
  • Responsible for risk mitigation, action plans, and issue resolution, along with proactively communicating changes, updates, and issues to all TMF stakeholders
  • Provides audit/inspection readiness support by driving TMF quality reviews in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs
  • Identify and implement improvements to document management processes to improve the quality of TMFs
  • Develop lessons learned and share across programs and foster a culture of constant improvement as a TMF ambassador
  • Review internal and vendor trial quality outputs to identify trends; develop process improvements, including reviewing and reporting metrics established for performance TMF reviews and providing action plans as appropriate

No matter your role at BridgeBio, successful team members are:

  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed

 

Education, Experience & Skills Requirements

  • 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

Experience & Skills:

  • 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

Other:

  • 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

What We Offer

  • 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
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
$155,000$195,000 USD

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

ML Bio Solutions Remote - United States Clinical Operations

Apply Now