Bridgebio Pharma, Inc. San Francisco , CA 94118
Posted 2 weeks ago
About Eidos Therapeutics & BridgeBio Pharma
Eidos 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 eidostx.com/ | https://bridgebio.com
Who You Are
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 assigned
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
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 required
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
Bridgebio Pharma, Inc.