Senior Director, Clinical Operations, Neurology

Job Description

Job Description

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

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.

Requirements : 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 :

What We Offer

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.