VP, Clinical Operations

Job Description

Description:

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.

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

Who You Are

We seek a top executive responsible for overseeing the Galacta global clinical operations group and all clinical trial programs from phase I to Phase III and/or on-market products, including oversight and management of clinical operations management functions. This full-time job requires excellent communication and interpersonal skills as well as technical, clinical operations, KOL interface, and inspection readiness abilities. This will be the first role in the Galacta clinical operations team, and requires a candidate who is both hands-on and willing to do the work, and who can set the vision and hire to build a team over time. We hope to hear from you.Requirements:

Leadership responsibility for Clinical Operations strategy, initiation and execution of clinical trials across all phases, including CRO/vendor selection, site engagement and contracts, CRO oversight, subject recruitment, and proactive risk management to ensure optimal conduct of clinical trials with a high level of data integrity.

Provides input into company objectives and creates clinical operations objectives to drive the overall success of programs and clinical trials.

Works cross functionally to support the development of protocols, data management strategies, and systems development of required reports and regulatory filings to gain product approval.

Accountable for ensuring the accuracy of departmental finances, including accruals, budgeting, and forecasting.

Manages, supports, and mentors the Clinical Operations team members to the highest quality of output on each of their individual studies within the development program.

Serves as Clinical Operations point of contact for strategic governance bodies (e.g., Safety Team), as well as portfolio planning.

Establishes key performance indicators to monitor clinical trial health, enable timely course corrections, and ensure the successful execution of clinical trials.

Develops operational outsourcing plan for managing clinical research activities, including activities to be performed in-house or through third-party relationships to complete clinical trials according to the strategic plan to support product approval.

Creates governance committees with key vendors (e.g., CROs) to provide leadership oversight and ensure operational excellence, including adherence to GCP and ICH.

Leads and/or contributes to the development of clinical operations SOPs, clinical development plans, and other Company initiatives as required.

Both hands-on driving of work, and vision-setting and team-building as the first member of the Galacta Therapeutics clinical operations team.

Education, Experience & Skills Requirements:

Advanced college degree preferred in a scientific or business discipline, or equivalent combination of education and experience

Minimum 15 years of industry experience with at least 10 years directly leading clinical operations

Previous experience with overseeing Ph1 through Ph3 clinical trials

Experience in building infrastructure, including the development of SOPs

Successful track record of leading clinical operations in a dispersed project team environment

Experience collaborating with investigators, study personnel, KOLs, scientific advisors, consultants, and contractors

Proficient in creating operational strategy and overseeing multiple clinical trials across a wide range of vendors

Solid understanding of overall drug development required with relevant therapeutic area experience preferred

Excellent understanding of GCP and ICH guidelines as well as other regulatory requirements

Both willing to be hands-on and in the details, and able to set a vision and strategy for the department over time

Strong leadership and interpersonal skills with the ability to clearly communicate operational strategy in a cross-functional environment

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

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 - up to 30%

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

Compensation Range: 297,119 - 395,000

Full-time