Senior Director, Clinical Operations

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. Originally carved out in 2024 after securing $300M in private financing, GondolaBio leverages cutting-edge biological research to discover, create, test, and deliver transformative medicines. Our pre-clinical stage program targets Neurofibromatosis Type 1 (NF1), a genetic condition where tumors grow on the nerves and skin, with a wide range of manifestations. Despite existing FDA-approved treatments, there remains a significant unmet need for safer and more efficacious options for NF1 patients.

About the role

You are a strategic and execution-minded clinical operations leader who thrives in a fast-paced, collaborative environment. You excel when the path isn’t fully defined, bringing a strong track record of leading global clinical trials, especially Phase 2. You take ownership of outcomes, build actionable plans, and drive delivery through internal teams and external partners. Comfortable in a lean, focused team, you’re willing to be hands-on and scale the team as needed.

Responsibilities

• Provide strategic and operational leadership for the launch and execution of global clinical trials across multiple regions, including the U.S., Europe, Australia, and China. Experience in China is highly preferred.
• Take ownership of end-to-end operational strategy and execution for developmental programs, balancing speed, cost, and risk across studies and geographies.
• Develop and maintain integrated study plans, including clinical protocols, timelines, budgets, and risk mitigation strategies to ensure milestone delivery with quality.
• Select and oversee CROs, clinical pharmacology units, and key vendors, building governance models that drive accountability and performance.
• Support site identification, qualification, and management, collaborating with Principal Investigators and study coordinators.
• Partner with cross-functional teams (Clinical Development, Safety, Regulatory, Biometrics, Clinical Supply, CMC, Translational) to align on operational feasibility and execution plans.
• Drive study start-up and conduct excellence, including feasibility, vendor management, enrollment, data quality, TMF readiness, and closeout.
• Proactively navigate ambiguous situations by identifying problems, proposing solutions, and unblocking teams to deliver outcomes.
• Establish and improve clinical operations processes, templates, and metrics as the organization scales.
• Contribute to pipeline growth activities, including operational diligence for new opportunities and integration planning.
• Maintain advanced knowledge of the therapeutic area and clinical trial setting, ensuring compliance with GxP standards.
• Lead or assist in writing, reviewing, and approving clinical project deliverables such as core documents and plans.

Requirements

• 10+ years of clinical operations/clinical management experience with increasing responsibility; senior leadership experience managing programs 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 the U.S. and ex-U.S.
• Strong knowledge of ICH-GCP and global clinical operations best practices; inspection readiness experience.
• Proven ability to lead through influence, align stakeholders, and drive execution in a lean environment.
• Track record of operating effectively with ambiguity—setting direction, making decisions, and delivering outcomes.
• Strong organizational, prioritization, and communication skills.
• Mandarin language skills preferred.
• Strategic thinking, proactive issue identification, and problem-solving skills.
• Ability to operate at all levels, from oversight to hands-on management.
• Willingness to travel as needed.

BA/BS degree preferred in a scientific or business discipline, or equivalent combination of education and experience.

Skills

• Patient Champions: Put patients first and uphold strict ethical standards.
• Entrepreneurial Operators: Drive practical solutions with an ownership mindset.
• Truth Seekers: Detail-oriented, rational, and humble problem solvers.
• Individuals Who Inspire Excellence in themselves and others.
• High-quality executors: Deliver against goals with precision and speed.

Benefits

• Patient Days: Hear directly from individuals living with the conditions we aim to impact.
• Culture inspired by values: Put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
• Decentralized model enabling program teams to focus on advancing science and helping patients.
• Ownership of vision for your program and career path.
• Collaborative, fast-paced, data-driven environment.
• Learning and development resources to support professional growth.
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs).
• Flexible PTO.
• Rapid career advancement for strong performers.
• Potential to work on multiple programs across therapeutic areas over time.
• Partnerships with leading institutions.
• Commitment to Diversity, Equity & Inclusion.

Pay

The base pay range for this position is $259,000 to $314,000 per year. Actual compensation will be determined based on experience, skills, qualifications, and location. A bonus plan and equity will also be offered.