Senior Director, Clinical Operations
Palo Alto, CA or Remote
About GondolaBio
GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.
Who You Are
You are an execution-minded clinical operations leader who thrives in a fast-paced, collaborative environment-and you're at your best when the path isn't fully defined. You bring a strong track record of leading global clinical trials, Phase 1-4, and you know how to move quickly without compromising quality. You take ownership of outcomes, not just tasks. You're a self-starter who can independently identify what needs to happen, build an actionable plan, and drive delivery through internal teams and external partners. You communicate crisply, escalate early with solutions, and stay calm and effective when timelines are tight or priorities shift. You enjoy building-teams, processes, and playbooks-and you're excited to bring senior-level operational leadership to a company that moves quickly and thinks strategically. Candidates must have direct experience managing clinical operations in ex-US markets such as Canada and the UK.
Essential Skills and Function
- Lead and deliver global Phase1-4 clinical trials.
- Experience in early development (FIH/SAD/MAD and other early-phase designs as applicable).
- 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 scientific and 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. Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators, study coordinators. Seek their input on development of robust study protocols, site selections and patient recruitment programs that deliver enrollment targets. Close engagement with study sites is essential to ensure timely and high-quality execution of clinical studies.
- 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; collaborate to present clinical study results to the cross functional team and to the company and external stakeholders.
- 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. Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms to apply knowledge to support a robust clinical development strategy.
- 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 scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB/EC and HA submissions/approvals, clinicaltrials.gov postings, site activations, monitoring plan and tools, CRF’s, DMP, edit checks, safety plan, Safety Evaluation Team and DMC charter, close-out plans, inspection readiness plans, and CSRs.
