Homeoffice GondolaBio Service Co, Inc. - Senior Director, Clinical Operations, Neurology chez GondolaBio Service Co, Inc.

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  

Who you are:

The Senior Director, Clinical Operations is a responsible for overseeing the global clinical operations for the neurology pipeline programs across phase I to Phase III and/or on-market products, including oversight and management of CROs. This Director has excellent communication and interpersonal skills as well as technical, clinical operations, vendor management, and inspection readiness abilities.

Responsibilities:

• Responsibility for 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.
• 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.
• 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 oversee clinical trials, 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 oversight and ensure operational excellence, including adherence to GCP and ICH.
• Contributes to the development of clinical operations SOPs, clinical development plans, and other Company initiatives as required.

Education, Experience & Skill Requirements: 

• Advanced college degree preferred in a scientific or business discipline, or equivalent combination of education and experience
• Minimum 10 years of industry experience with at least 5 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
• Previous experience managing CROs and key clinical vendors
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Proficient in creating operational strategy and overseeing multiple clinical trials across a wide range of vendors

 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 Gondola Bio  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 $255,000 to $285,000 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.