Senior Director, Clinical Operations

🔥 21 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $244k - $295k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 1%

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GondolaBio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $300M Venture Round - GondolaBio on 2024-08

Healthcare • Consulting • Manufacturing

GondolaBio is a clinical-stage biopharmaceutical company launched in 2024 and affiliated with BridgeBio Pharma, focused on developing breakthrough therapeutics for patients with genetic diseases. The company uses a lean, decentralized approach to accelerate early-stage research and development across multiple modalities (including small molecules and oligonucleotide therapies) and is building a diverse pipeline targeting rare and underserved genetic conditions such as EPP/XLP with its lead program PORT-77. GondolaBio centers patient needs and aims to bring disease-modifying treatments more quickly to populations lacking approved therapies.

📋 Description

• Lead and deliver global Phase 1-4 clinical trials • Lead early development studies, including FIH/SAD/MAD and other early-phase designs • Own end-to-end operational strategy and execution for developmental programs across studies and geographies • Develop and maintain integrated study plans • Participate in designing, implementing, and reviewing clinical protocols and study reports • Ensure milestones are met with quality, attention to detail, and risk mitigation • Select CROs, clinical pharmacology units, and key vendors • Build governance and oversight models for accountability, performance, and predictable delivery • Identify, qualify, manage, and maintain relationships with clinical trial sites and Principal Investigators • Support robust protocols, site selection, patient recruitment, and enrollment targets • Partner with Clinical Development, Safety, Regulatory, Biometrics, Clinical Supply, CMC, and Translational stakeholders • Drive country/site feasibility, study start-up, vendor management, enrollment execution, data quality, TMF and inspection readiness, closeout, and timely study execution • Deliver high-quality clinical study data and present results to cross-functional teams and external stakeholders • Navigate ambiguity, identify problems, propose options, make decisions, and unblock teams • Establish and improve clinical operations processes, templates, and metrics • Contribute to pipeline growth, operational diligence, and integration planning • Maintain advanced knowledge of the therapeutic area, product, clinical trial setting, literature, competitive intelligence, and treatment paradigms • Own team role training and collaborate with Quality Assurance on GxP-compliant training • Lead or assist in writing, reviewing, and approving clinical project deliverables, submissions, monitoring plans, CRFs, data management plans, safety plans, charters, closeout plans, inspection readiness plans, and CSRs

🎯 Requirements

• BA/BS or equivalent in a scientific or health-related discipline; advanced degree preferred • 12+ years of clinical operations/clinical management experience with increasing scope and responsibility • Senior leadership experience managing programs and/or teams • Direct experience managing clinical operations in ex-US markets such as Canada and the UK • Operations experience in Neurology or rare disease preferred • Demonstrated success leading international trials and complex vendor ecosystems • Direct, hands-on experience running Phase 1-4 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 • Ability to operate effectively with high ambiguity, set direction, make decisions, and take accountability for delivery • Strong organizational, prioritization, multitasking, verbal communication, and written communication skills • Strategic thinking, proactive issue identification, excellent judgment, and problem-solving skills • Ability to operate and cooperate at all project levels, from oversight to hands-on management of day-to-day activities • Willingness to travel as necessary, consistent with project needs

🏖️ Benefits

• Patient Days • Culture inspired by company values • Access to learning and development resources • Robust and market-competitive compensation and benefits package • Performance bonus • Equity • Health programs • Welfare programs • Retirement programs • Flexible PTO • Rapid career advancement for strong performers • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas • Partnerships with leading institutions