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Director/Sr. Director, Head of TMF Operations

Company: BridgeBio Pharma
Location: San Francisco
Posted on: June 10, 2024

Job Description:

Director/Sr. Director, Head of TMF OperationsEidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

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 aims 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 - The Director/Sr. Director, Trial Master File (TMF) Operations is accountable for the leadership of the TMF organization, inclusive of TMF technology & systems, TMF operations, and TMF inspection readiness. They are responsible for TMF process development and implementation and will ensure processes are designed to support the business and TMF needs across the entire Research & Development (R&D) organization of Eidos and BridgeBio. Implementing appropriate controls, standards, and metrics to ensure oversight and compliance in the short and long term.This position will also be responsible for resource management (budget and headcount), development of their staff, and for leading an organization of continuous improvement and driving culture best practices to TMF industry standards.Responsibilities

  • Leads TMF team in establishing strategic direction and operational management of TMF, including, process renovation, system & technology, inspection readiness, and outsource & vendor governance
  • Lead the team to address existing and potential gaps in the TMF system and processes to prepare the internal or external teams for health authority inspections
  • Lead TMF audit and inspection readiness by conducting TMF/eTMF content quality reviews at defined time points, collaborating with internal team members, providing periodic updates, and verifying study specific information on a regular basis
  • Lead the identification and execution of CAPAs related to TMF process and systems
  • Ensure essential documents can be mapped and identified in eTMF
  • As needed, be the face of TMF with regulatory inspectors to address TMF-related inquiries
  • Drives and leads the development of study-specific, cross-departmental TMF Plans and TMF Indexes coordinating cross functional teams
  • Develop and implement a roadmap for the eTMF system and process evolution at Eidos and Bridgebio
  • Be a member of Clinical sub team to provide TMF leadership for ongoing studies
  • Establish, lead and chair of TMF Governance forum - responsible communication, escalation and alignment of all aspects pertaining to the TMF and collaboration cross functionally with relevant key stakeholders
  • Effectively manage team meetings, by ensuring that objectives are clearly defined, capturing and disseminating meeting outcomes, information, and action items, and following up on critical actions with teams
  • Foster leadership, strategic thinking, and business acumen while setting high standards that drive alignment, collaboration, accountability, and goal achievement within program subteams
  • Reporting and presentation of TMF to the functional heads, and other key stakeholders
  • Clearly and proactively anticipate, identify, track, communicate, and propose solutions for discrepancies in priorities and plans, prioritize complex and multiple/conflicting responsibilities and/or issues
  • Committed to maintaining a work environment that supports BBIO's core values
  • Other duties as assignedNo 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 speedEducation, Experience & Skills Requirements
      • Bachelor's degree or equivalent required (scientific or healthcare discipline preferred). Advanced degree preferred
      • Minimum of 10 years of working in clinical research and drug development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience with TMF, clinical documentation and/or records & information management
      • Strong understanding of TMF processes and awareness of evolving regulatory requirements related to records management to support the development and delivery of a TMF Operations strategy
      • Strong understanding of the industry wide TMF Reference Model
      • Extensive knowledge of regulatory standards (e.g. ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management and records management (e.g. DIA TMF reference model)
      • Rare disease experience preferred
      • Ability to influence teams to meet or exceed Program deadlines consistently
      • Experience in leading and managing team meetings; proven ability to create opportunities for meeting efficiency
      • Demonstrated team management and team-building skills; enthusiastic about creating a thriving environment for teamwork, collaboration, and cooperation
      • Effective communicator who can develop strong relationships to facilitate Program operations outside the context of formal meetings; able to effectively communicate with supervisor, co-workers, and external partners daily, in-person, by phone, and email
      • Proactive problem solver with detailed organizational skills
      • Has expert skills with the Microsoft Office Suite: Excel, Program, PowerPoint, Word, and Outlook; ability to create compelling presentations for internal and external use
      • Up to 5% travel may be requiredWhat 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 -
        • 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. Are you legally authorized to work in the United States? -*
          Please select If hired by BridgeBio or one of its affiliates, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)? -*
          Please select If you answered, "yes" to the previous question, please provide additional context below.
          U.S. Standard Demographic QuestionsWe invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process. How would you describe your gender identity? (mark all that apply)
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Keywords: BridgeBio Pharma, San Francisco , Director/Sr. Director, Head of TMF Operations, Accounting, Auditing , San Francisco, California

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