Vice President, Clinical Development

Job 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, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

Galt Therapeutics is an early clinical stage biotechnology company developing a novel potential best-in-class AAV gene therapy for classic galactosemia, a severe genetic metabolism disorder.

Who You Are

We seek a top clinical development executive responsible for overseeing the Galactosemia Clinical Development Program, including Phase I to Phase III clinical trials. This role will be primarily accountable for clinical trial execution encompassing study design, oversight and management. Reporting to the Chief Operating Officer, this job requires excellent communication and interpersonal skills as well as technical, clinical operations, KOL engagement, and inspection readiness abilities. We hope to hear from you.

Requirements

• Direct and oversee the design and implementation of all stage clinical projects
• Design scientifically rigorous and maximally cost-effective clinical development programs and support their efficient implementation with a focus on quality
• Co-lead development and contribute to review of Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, ISS, and the documentation for regulatory filings
• Provide leadership and clinical development expertise to the overall organization, including the clinical development, clinical operations, biometrics, toxicology, and translational science teams 
• Collaborate with Regulatory Affairs to develop strategies and tactical work plans during clinical development and in preparation for the anticipated US and global filings
• Lead the preparation and management of timely regulatory submissions, including INDs, briefing documents, clinical protocols, NDAs
• Set a high standard and example of urgency, work quality, and effectiveness
• Contribute to due diligence and gap analysis on potential new GondolaBio assets
• Perform all other duties as assigned

Education, Experience & Skills Requirements

• Doctorate Degree in Medicine (MD) is required for the position.
• Training in pediatrics preferred but not required
• A proven leader with a minimum of 10+ years pharmaceutical/biotechnology industry experience in multiple phases of development
• Experience with gene therapy
• Knowledge of clinical trial management, data management, and drug development process; ability to collaborate with, support, and oversee medical monitors (study physicians)
• Experience with the global regulatory environment (incl. FDA, EMA) and respective standards, including hands-on experience in international drug development
• Deep knowledge and understanding of drug development process, regulatory requirements, and environment
• Able to drive strategic thinking and plans for successful clinical trial outcomes
• Dynamic individual with excellent written and communication skills 
• Ability to set priorities, work independently and deliver results in a timely manner
• Recent experience of IND and NDA/BLA submissions strongly preferred
• Experience in preparing for and interfacing with regulatory authorities
• Vital planning, organizational, and leadership skills
• Results-oriented. Strong initiative, accountability, and willingness to take ownership and drive projects to completion
• Experience in driving collaborations and working with external partners, including building networks with key opinion leaders (KOL) and investigators, business partners
• Ability to deliver effective presentations both internally and externally, and strong networking abilities and creativity
• Effectiveness as a matrix leader and ability influence on multiple levels of the organization
• Strong manager and people developer
• Strong interpersonal, communication, and organizational skills
• Able to proactively identify and solve problems under pressure
• Motivated to work in a fast-paced, highly accountable, small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills. Demonstrated leadership skills and ability to collaborate successfully with multiple functions and external vendors in a cross-functional team environment
• Capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail
• Strong written and oral communication skills, including presentation skills.
• Solid critical, strategic, and analytical thinking skills
• Travel required

What We Offer:

• Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
• Collaborative business environment
• Excellent compensation package (Base, Performance Bonus, Equity)
• Excellent benefits package
• Flexible PTO
• A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
• Work with the most productive groups of R&D operators in the industry
• A platform for meaningful scientific contributions to shine