GondolaBio Service Co, Inc. - SR, Clinical Trial Manager

GondolaBio Service Co, Inc. - SR, Clinical Trial Manager





















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SR, Clinical Trial Manager






GondolaBio Service Co, Inc.





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SR, Clinical Trial Manager




Fully Remote •
Palo Alto, CA- Hybrid









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Description
Company BackgroundGondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. Originally carved out of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. GondolaBio aims to leverage cutting-edge biological research to discover, develop, test, and deliver transformative medicines to treat patients with genetic diseases.Portal Therapeutics is an early clinical stage biotechnology company, and the lead program in GondolaBio’s portfolio. Portal is developing a novel potential best-in-class therapy for erythropoietic protoporphyria, a severe genetic disease of the blood that results in extreme sensitivity to sunlight and liver damage.Portal Therapeutics, Inc. is a growing biotechnology company dedicated to developing innovative therapies for patients with rare diseases. As we expand our clinical portfolio, we are seeking a dynamic and experienced Senior Clinical Trial Manager (Sr. CTM) to join our Clinical Operations team. Who You AreYou are a clinical operations professional who is excited to “roll up your sleeves” and continue to learn how trials are executed end-to-end in a small biotech setting. You are highly organized, proactive, and comfortable operating with ambiguity, able to anticipate needs, solve problems, and keep study teams aligned. You take pride in being dependable and detail-oriented, while still seeing the bigger picture.
Requirements
Key ResponsibilitiesTrial Planning & ExecutionLead global clinical trial(s) from start-up through close-out.Develop and maintain trial management plans, timelines, risk assessments, and budgets.Oversee CROs, vendors, and study sites to ensure deliverables are met.Site & Vendor ManagementDrive site feasibility, selection, and activation processes.Manage CROs and third-party vendors, ensuring quality deliverables and performance oversight.Support site relationship management and act as an escalation point for operational issues.Regulatory & ComplianceEnsure compliance with ICH GCP, FDA, EMA, and other local regulations.Collaborate with Regulatory Affairs, Quality, and Pharmacovigilance on submissions, safety reporting, and audits/inspections.Cross-functional CollaborationPartner with Clinical Development, Data Management, Biostatistics, Medical Monitoring, Translational Medicine, DMPK, and Drug Supply teams.Contribute to protocol development, ICFs, monitoring plans, and other key documents.Represent the Clinical Operations in internal and external meetings.Leadership & MentorshipProvide guidance to junior Clinical Operations staff.Contribute to building processes, SOPs, and best practices for a growing biotech organization. Qualifications & ExperienceBachelor’s degree in life sciences, nursing, pharmacy, or related field 7+ years of clinical research experience, with at least 3+ years as a Clinical Trial Manager (global trial management strongly preferred).Demonstrated experience leading Phase I–III global studies in rare disease, oncology, or specialty therapeutic areas.Strong knowledge of ICH GCP, FDA, EMA, and global regulatory requirements.Proven ability to manage CROs, vendors, and clinical sites.Experience with budget and timeline management.Excellent communication, leadership, and problem-solving skills.Thrives in a fast-paced, startup environment with a hands-on, solution-driven approach. What We OfferPatient Days, where we are fortunate to hear directly from individuals living with theconditions we are seeking to impact throughout the year and learn how we can improve oureffortsA culture inspired by our values: put patients first, think independently, be radicallytransparent, every minute counts, and let the science speakAn unyielding commitment to always putting patients first.A de-centralized model that enables our program teams to focus on advancing science andhelping patients. Our affiliate structure is designed to eliminate bureaucracy and putdecision-making power in the hands of those closest to the scienceA place where you own the vision – both for your program and your own career pathA collaborative, fast-paced, data-driven environment where we inspire ourselves and eachother to always perform at the top of our gameAccess to learning and development resources to help you get in the best professionalshape of your lifeRobust and market-competitive compensation & benefits package (Base, PerformanceBonus, Equity, health, welfare & retirement programs)Flexible PTORapid career advancement for strong performersPotential ability to work on multiple GondolaBio Pharma programs across multiple therapeuticareas over timePartnerships with leading institutionsCommitment to Diversity, Equity & InclusionThe base pay range for this position is $170,000 to $197,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.


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