Senior Director, Clinical OperationsRequirements
Essential Skills and Function- Provide strategic and operational leadership for the launch and execution of global clinical trials potentially across multiple regions, including the U.S., Europe, Australia, and China. Experience navigating clinical trial start-up and execution in China is highly preferred.
- Experience in early development (FIH/SAD/MAD and phase 2) is a must. Ph3 and registrational experience very preferred but not required
- Take ownership of end-to-end operational strategy and execution for developmental programs, balancing speed, cost, and risk across multiple studies and geographies.
- Develop and maintain integrated study plans, including participating in the design, implementation and review of clinical protocols and study reports for operational accuracy, timelines, budgets, and risk mitigation strategies; ensure milestones are met with quality and attention to detail.
- Select CROs, clinical pharmacology units, and key vendors; build governance and oversight models that drive accountability, performance, and predictable delivery. Support identification, qualification, management, and maintenance of close engagement with clinical trial sites, including collaborating with Principal Investigators and study coordinators
- Partner closely with cross-functional stakeholders (Clinical Development, Safety, Regulatory, Biometrics, Clinical Supply, CMC, Translational) to align on operational feasibility and execution plans.
- Drive study start-up and conduct excellence (country/site feasibility, start-up strategy, vendor management, enrollment execution, data quality, TMF/inspection readiness, closeout and timely study execution. Deliver high-quality clinical study data.
- Proactively navigate ambiguous situations: identify the real problem, propose options, make decisions, and unblock teams to deliver outcomes.
- Establish and continuously improve fit-for-purpose clinical operations processes, templates, and metrics as the organization scales.
- Contribute to pipeline growth activities as needed (operational diligence for new opportunities; integration planning for new programs/vendors).
- Acquire and sustain advanced knowledge of the therapeutic area and product and clinical trial setting.
- Take overall responsibility for role training for the team and work with Quality Assurance to develop, maintain and document appropriate training for compliance with GxP standards.
- Lead or assist in writing, reviewing, and/or approving clinical project deliverables such as core documents and plans
Preferred Education and Experience- BA/BS degree preferred in a scientific or business discipline, or equivalent combination of education and experience
- 10+ years of clinical operations/clinical management experience with increasing scope and responsibility; senior leadership experience managing programs and/or teams.
- Demonstrated success leading international trials and complex vendor ecosystems (CRO oversight, governance, budgets, timelines, and performance management).
- Direct, hands-on experience running Phase 1 and 2 trials, healthy volunteer studies, SAD/MAD/ PoC in US/ex-US
- Strong knowledge of ICH-GCP and global clinical operations best practices; strong quality mindset and inspection readiness experience.
- Proven ability to lead through influence, align diverse stakeholders, and drive execution in a lean environment.
- Track record of operating effectively with high ambiguity-setting direction, making decisions, and taking accountability for delivery.
- Strong organizational skills and the ability to prioritize and multi-task with exceptional verbal and written communication skills
- Mandarin language skills preferred
- Possess strategic thinking and proactive identification of issues, excellent judgment, and problem-solving skills
- Ability to operate and cooperate at all levels within a project, from oversight to hands-on management of day-to-day activities
- Willingness to travel as necessary, consistent with project needs.
No matter your role at GondolaBio, 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
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.
- 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
The base pay range for this position is $259,000 to $314,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.
