Clinical Trial Manager

Description:

Company Background

GondolaBio 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 Clinical Trial Manager to join our Clinical Operations team.

Who You Are

You 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:

Responsibilities

• Support day-to-day execution of one or more clinical studies (Phase 1–3, as applicable), partnering closely with the Sr. CTM/Clinical Operations lead and cross-functional study team.
• Maintain core study tracking (e.g., timelines, enrollment, site start-up metrics, TMF completeness, vendor deliverables) and escalate risks early with proposed options.
• Coordinate study start-up and site readiness activities (e.g., feasibility support, essential document collection and reviews, site activation).
• Support vendor and CRO oversight by tracking action items, reviewing deliverables for completeness, and ensuring follow-through across stakeholders.
• Contribute to inspection readiness and quality-by-design execution (e.g., filing, reconciliation support, controlled document workflows, follow-up on deviations/CAPAs as assigned).
• Assist in review of study plans and key documents (protocol, ICFs, monitoring plans, vendor plans, manuals) and coordinate review cycles.
• Participate in study meetings; draft agendas, minutes, decision logs, and action registers; ensure decisions are documented and communicated.
• Partner cross-functionally (Clinical Development, Data Management, Regulatory, QA, etc.) to keep operational activities aligned to study goals and quality delivery.

No matter your role at GondolaBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who deliver with precision, urgency, and integrity

Education, Experience & Skills Requirements

• Bachelor’s degree in life sciences, nursing, public health, or related field (or equivalent relevant experience).
• 5+ years of experience in clinical research/operations (biotech, pharma, CRO, or site), including exposure to GCP/ICH and clinical trial documentation.
• Strong organizational skills: able to manage multiple priorities and meet deadlines in a fast-moving environment.
• Clear written and verbal communication skills; comfortable driving follow-ups and documenting decisions.
• Demonstrated resourcefulness and independent problem-solving; able to propose solutions, not just identify issues.
• Working knowledge of CTMS/EDC/eTMF tools preferred, strong Microsoft Office suite and SharePoint experience.
• Rare disease experience is a plus, not required.

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the
• conditions we are seeking to impact throughout the year and learn how we can improve our
• efforts
• A culture inspired by our values: put patients first, think independently, be radically
• transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first.
• A de-centralized model that enables our program teams to focus on advancing science and
• helping patients. Our affiliate structure is designed to eliminate bureaucracy and put
• decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each
• other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional
• shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance
• Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic
• areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion

The base pay range for this position is $133,000 to $161,000 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.