Director, Clinical Operations at Sionna Therapeutics Inc

Description

Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co-founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function.

Position Summary:

Sionna Therapeutics is seeking a Director of Clinical Operations to work collaboratively with the co-Director, Clinical Operations, internal teams, external vendors, and key stakeholders to support clinical trials and ensure compliance with regulatory standards. The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations across programs with multiple studies. This individual possesses clinical operations expertise with a track record of success working with peers, clinical operations team members, and cross-functional stakeholders to drive programs through all phases of clinical trials (Phase I-III). 

Responsibilities:

• In close collaboration with the co-Director of Clinical Operations, provide leadership for clinical trial execution in support of corporate goals, while leading and mentoring the clinical operations team 
• Provide operational clinical strategies to achieve corporate, program and departmental goals
• Oversee and contribute to the development and coordination of operational plans for clinical studies 
• Drive the selection and oversight of CROs, contract laboratories and other vendors, clinical budget planning and adherence to plan 
• Oversee and help manage deliverables, evaluates CRO and vendor performance and proactive communication to manage issues and solutions 
• Ensure adherence to regulatory requirements pertaining to clinical operations (ICH, FDA, EMA, etc.) and GCP guidelines 
• Contribute to and help manage, if applicable, the preparation and review of clinical documents including clinical Protocols, Informed Consents, Investigator Brochure, Investigational New Drug Applications, clinical study reports  
• Manage the identification and evaluation of investigators and sites and actively assess and communicate site activation and subject enrollment against established targets 
• Manage the identification, evaluation, and oversight of clinical study third party vendors; work with QA on audit process 
• Support the oversight of clinical trial operations and all aspects of site management in accordance with ICH/GCP standards and SOP’s 
• Work with the Head of Clinical Development Operations to build out and define best practices and processes for the Clinical Operations team 
• Provide regular study updates, anticipate and communicate potential operational risks or study issues and to prepare contingency plans with minimal oversight 
• Manage and mentor members of the clinical operations team and provide performance reviews and development of staff
• Maintain knowledge of therapeutic area in order to ensure best practice across all activities
• Build collaborative relationships with other key internal and external stakeholders to facilitate the planning and execution of clinical trials, operational strategy, risk management and mitigation
• Additional tasks and responsibilities as required  

Requirements

• Bachelor's Degree or equivalent (health-related field preferred) 
• 10+ years' experience in pharmaceutical/life science industry, with significant experience in clinical operations (global clinical trial experience is strongly preferred)
• 8+ years' experience managing people and leading teams
• Proven experience with clinical site selection, initiation, management, and enrollment 
• Ability to understand how study-related decisions impact other functional areas and deliverables   
• Knowledge of drug development and project management from pre-IND though NDA 
• Expertise in global regulatory and compliance requirements for clinical research, including but not limited to, US CRF, EU CTD and ICH GCP  
• Significant experience working in cross-functional, team-oriented environments 
• Excellent communication skills, both written and verbal, with a proven track record of keeping key stakeholders and management informed of status, issues, and recommended solutions 
• Excellent organizational and project management skills and ability to work independently 
• Ability to work in a small organization, adapt to changing priorities, and manage tasks in a fast-paced environment

Salary Range: $200,000 - 235,000