GondolaBio

Research Scientist

• Design and execute in vivo pharmacology studies across Neurology programs in rodents and non-human primates toward IND submission
• Partner with toxicology and translational teams to ensure rigorous, reproducible, and translatable in vivo pharmacology data
• Inform dose selection and go/no-go decisions
• Develop and implement pharmacodynamic and efficacy assessments
• Troubleshoot assays and quality-control data from CROs and external partners
• Manage CRO relationships and monitor study progress
• Identify emerging study risks and present progress updates in team meetings
• Analyze in vivo pharmacology endpoints, including PK/bioanalysis and pharmacodynamic and/or efficacy endpoints

Principal Scientist, In Vivo Pharmacology, Neurology

Clinical Operations

• 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

Principal Scientist, In Vivo Pharmacology, Neurology

Senior Director, Clinical Operations