About BridgeBio Oncology Therapeutics
BridgeBio Oncology Therapeutics (“BBOT”) is a private biotech company dedicated to developing innovative new therapeutics to address dire unmet needs in oncology. Founded on a commitment to patients, scientific excellence, and operational agility, we understand that every minute counts in our efforts to develop new therapies to transform the lives of people living with cancer. Driven by a team of experienced scientists, clinicians, and industry experts, our team utilizes cutting-edge structure-based drug discovery techniques to target some of oncology’s most challenging and validated molecular targets, including KRAS and PI3Kα. BBOT has a pipeline of several promising differentiated drug candidates and strong investor support, the combination of which positions us to deliver meaningful benefit to patients. Our offices and laboratory are in South San Francisco, though our colleagues and collaborators span the country and globe.
To learn more, visit us at bridgebiooncology.com
Position Summary
The Sr. Director or Director of Clinical Data Management will be responsible for overseeing Data Management operational activities through all study phases for program or studies assigned. This includes supporting the design, development, validation, implementation, maintenance and close-out of clinical study databases for all clinical studies. The Sr. Director or Director of Clinical Data Management will be accountable for a high level of quality for deliverables from within Data Management and from Data Management vendors. The Sr. Director or Director of Clinical Data Management will be responsible for managing and building the data management group.
Who You Are
- 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 under a changing environment
- Ability to multi-task, prioritize and solve problems
Responsibilities
- Oversees data management staff, study activities, and CRO
- 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 as a leadership role
- Advises on best practices for Data Management and serves as an escalation path for data management decision or recommendation
- Manage ongoing data review activities, including identification, tracking and resolution of data issues (e.g., clinical data listing reviews, database lock activities, etc.)
- Ensures data management timelines and deliverables, including metric output, are detailed and communicated to the study team on a regular basis
- Provides oversight of external data providers and corresponding data reconciliation (e.g., IRT, safety, central and specialty labs, patient reported outcomes, etc.)
- Provides oversight of data reconciliation across data transfers and documentation of Data Transfer Plans for study
- Provides guidance in the authoring, review and/or approval of 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 documents are maintained throughout the duration of the study
- 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.
- Oversees the conduct of clinical data review and preparation for DMC, DSUR, Database Freeze, Database Lock and/or other data deliverables
- 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 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 of 12 years of Data Management experience in the pharmaceutical and/or biotech space
- Minimum of 6 years of managing data management staff
- 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
- Experience with performance assessments
- Experience with presenting material to Sr. Management/Leadership
- Previous experience working with an Electronic Data Capture system (EDC)
- Proficient with MS Word, Excel and PowerPoint
What We Offer
- A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
- 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.
- Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
- Flexible PTO
- Rapid career advancement for strong performers
- Commitment to Diversity, Equity & Inclusion