Associate Director, Clinical Operations
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 Associate Director, Clinical Operations will be responsible for coordinating and implementing clinical operations activities of multiple clinical trials. Also, you will be responsible for adequately resourcing, managing, and executing clinical studies within budget and per established timelines and quality standards.
Responsibilities
- Study Planning and Management. Coordinate and actively participate in the development and updating of study-related documents (investigator brochure, clinical protocols, and amendments, informed consent forms, case report forms, clinical study reports, adverse event reporting, site training manuals) and analysis plans (including data collection and management); Monitor study progress and maintain timeline from initiation through the publication of study results; work very closely with the clinical lead to advance the studies.
- Quality control. Responsible for development, training, implementation, and compliance of Standard Operating Procedures; Develop quality control processes and monitoring plans to ensure that all clinical activities are compliant with Good Clinical Practices and regulatory guidelines.
- Clinical Trial Budgeting. Work with the finance department on the development and negotiation of trial site budget and clinical trial agreements; Forecast and manage clinical trial budgets and FTE costs; Ensure accurate accruing of study costs; Review vendor invoices against contract and work completed; Oversee reconciliation of site payments against patient visits to ensure proper payments; Identify and communicate variances.
- Trial Site Management. Cultivate and maintain strong relationships with investigators and trial site administrators; Organize investigator meetings as needed; Lead effective communications with trial sites for specimen tracking, study conduct, and timely data review to identify trends and discrepancies; Contributes to the development of abstracts, presentations, and manuscripts for studies.
- Vendor Management. Responsible for collecting and preparing all information needed to facilitate selection, on-boarding, and management of CRO and vendors for outsourced activities; develop statements of work, budgets, and timelines; Responsible for gap analysis, performance management, risk management, and issue resolution.
- Supply Chain Management. Coordinate and plan for availability of clinical and non-clinical supplies required for trial execution
- 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 in a scientific discipline or equivalent is required, and an advanced degree is preferred
- Requires at least ten years of biopharma industry experience (relevant clinical trials experience, in the biotechnology, pharmaceutical, CRO, medical device industry) with at least seven years managing clinical trials
- Demonstrated ability to successfully develop, implement, manage and complete rare disease clinical trials on time and budget
- Experience working on a cross-functional team leading to the delivery of an NDA, BLA, or other necessary regulatory filings
- Expert working knowledge of study initiation, execution, analysis, and closing procedures
- Intimate knowledge of GCP and strong working knowledge in FDA, Good Clinical Practices and ICH regulations and guidelines and the application to the conduct of clinical trials
- Experience with investigator-initiated and industry-sponsored studies
- Experience in Quality Assurance, SOP writing, CAPA preparation, and successful closure
- Experience in working with clinical trial teams, including data management, clinical sciences, medical monitors, safety, biostatistics, regulatory, and QA
- Excellent leadership, organizational, and multi-tasking skills in a fast-paced start-up environment
- A very dynamic and energetic, hands-on approach to the challenges
- Excellent written and verbal skills and strong interpersonal skills required
- Deep understanding of clinical trial design, protocol development, and review running the clinical trial meetings
- Ability to build and maintain strong working relationships within the department and cross-functionally to meet a project or corporate goal
- Must be able and willing to travel periodically
- Experience with Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
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
- $175,000 - $215,000 a year
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. The anticipated salary range for candidates for this role who will work in California is $175,000 to $215,000/year. 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, and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.