Senior Director, Clinical Operations

GondolaBio

. Lead and deliver global Phase 1-4 clinical trials .

Posted 9/15/2026full-timeRemote • California • United StatesSenior💰 $244,000 - $295,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in leading global Phase 1-4 clinical trials, with a strong focus on operational strategy, vendor management, and compliance with ICH-GCP standards. Proven ability to navigate complex clinical environments, drive execution, and maintain high-quality study data while collaborating with cross-functional teams.

Highest-signal resume keywords

Clinical Operations ManagementPhase 1-4 Trial LeadershipICH-GCP KnowledgeVendor ManagementStrategic Thinking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial DesignStudy Protocol DevelopmentRisk MitigationData Management PlansInspection ReadinessPatient Recruitment StrategiesOperational Strategy ExecutionClinical Project DeliverablesFeasibility StudiesMultinational Trial Management

Soft Skills

Strong Communication SkillsOrganizational SkillsProblem-Solving SkillsDecision-MakingStakeholder Alignment

Industry Keywords

Clinical TrialsNeurologyRare DiseaseCRO SelectionClinical DevelopmentRegulatory ComplianceGxP ComplianceCross-Functional CollaborationClinical Operations Best PracticesGlobal Clinical Operations

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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