Associate Director, Clinical Data Management

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a clinical-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 product candidate, 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, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, 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 Associate Director/Director, Clinical Data Management will be responsible for supporting all aspects of data management from study start-up to database lock, including EDC design, data review/cleaning, query management, data reconciliation, and data transfer specifications

Responsibilities:

• Interfaces with study team, vendors, and sites to ensure that data management activities are performed consistently and deliverables are of high-quality
• Represents Data Management in study team meetings and facilitates cross-functional activities (e.g., clinical data listing reviews, database lock activities, etc.)
• Oversees and performs ongoing data review activities, including identification, tracking, and resolution of data issues
• Ensures data management timelines and deliverables, including metric output, are detailed and communicated to the study team regularly
• Provides oversight of external data providers and corresponding data reconciliation (e.g., IRT, safety, central and specialty labs, the patient-reported outcomes, etc.)
• Provides oversight of data transfers and documentation of Data Transfer Plans for study
• Authors, reviews, and/or approves various study-related documents and plans (e.g., Data Management Plans, eCRF Specifications, Edit Check Specifications, eCRF Completion Guidelines, Data Transfer Plans, etc.) and ensures records are maintained throughout the study
• Participates and/or oversees database development (e.g., CRF development, edit check development, User Acceptance Testing, etc.)
• Coordinates and/or provides training on data management systems, reporting tools, etc.
• Contributes to preparation, conduct, and follow-up on Investigator Meetings
• Participates in vendor selection and contract negotiation process, including RFPs and bid defense meetings, as applicable
• Participates in the development and maintains a working knowledge of study protocols and any amendments
• Participates as subject matter expert during regulatory inspections and/or vendor audits
• Contributes to the development of Data Management SOPs and Working Instructions, in addition to cross-functional SOPs, as applicable
• Ensures adherence to ICH GCP Guidelines and Good Clinical Data Management Practices
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 towards 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 of 8 years of Data Management experience in the pharmaceutical and/or biotech space, as a lead role, and/or management experience a plus
• Bachelor’s degree or equivalent
• Working knowledge of GCP ICH and GCDMP guidelines and the clinical development process
• Experience as Data Management Lead in all phases of clinical trials
• Experience managing vendors, including performance assessments
• Previous experience working with an Electronic Data Capture system (EDC)
• Proficient with MS Word, Excel, and PowerPoint
• Strong interpersonal, communication (written and verbal), and organizational skills
• Demonstrated ability to work independently, as well as part of a multi-functional study team
• Ability to motivate a team to work effectively in a changing environment
• Ability to multi-task, prioritize and solve problems

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 – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.