Senior Clinical Project Manager - Sionna Therapeutics

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 Senior Clinical Project Manager (Sr. CPM) who will be responsible for all aspects of clinical study management, providing performance metrics, overseeing the CRO and other vendors and helping to ensure the quality of deliverables. This person will also lead functional team members, CROs and vendors to successfully deliver clinical studies in collaboration with the Director of Clinical Operations. Also, as needed, the person in this role will support and help develop clinical operations SOPs as needed, in conjunction with QA and the Director of Clinical Operations. This position reports to the Director of Clinical Operations.

Key Responsibilities:

• Oversees site study activities, quality, timelines and the study budget with internal functional leads, CRO and vendors to ensure that the overall project objectives are met
• Oversee and participate in study start-up and ensure all startup activities, including site selection and activations are aligned with internal timelines
• Partner with the CRO to ensure participant enrollment targets are met
• Work with CRO to ensure site and data monitoring strategies are developed and carried out effectively
• Initiate and build professional relationships both with clinical site staff and CRO and vendor partners
• Responsible for the development and management of clinical study documents including, but not limited to, Protocols and amendments, Informed Consent Forms (ICFs), Protocol Administrative Clarifications/Notes to File, confidentiality agreements, translated clinical documents
• Responsible for helping to develop, track, review, and manage study related plans and processes, including but not limited to Investigator agreements (CTA), clinical monitoring plan (CMP), safety monitoring plan (SMP), lab manuals, protocol deviations, etc.
• Oversee monitoring activities, ensure compliance with the CMP, perform site monitoring and co-monitoring visits as needed; review of monitoring visit reports
• Closely oversee CRO and study vendors, as applicable, to ensure compliance with ICH/GCP requirements and internal SOPs, where applicable
• When applicable, manage and work with translation vendor to prepare clinical, subject-facing documents for IRB/EC submissions
• Participate in data review and query management to ensure quality data and site performance in accordance with the protocol
• Participate in the UAT of clinical databases
• Responsible for oversight and maintenance of the TMF and ensuring related SOPs and TMF plans are being followed
• Participate in CRO and clinical vendor identification and selection for new studies
• Help build the clinical operations team, including interviewing new candidates; potential for direct report management
• Help mentor and train junior members of the clinical team in the area of clinical operations
• Help to ensure studies are “inspection ready” at all times
• Support and help to drive the development, review, approval, training, adherence to and life-cycle management of GxP SOPs

Minimum Qualifications:

• Bachelor’s degree or equivalent in health-related field preferred
• 7+ years of experience in the pharmaceutical/biotechnology industry which includes experience as a Clinical Study Lead for a multi-region/multi-site study with a successful proven track record
• Solid understanding of clinical development process from IND to NDA/BLA submission
• Proficiency in the areas of clinical site selection, initiation and management
• Excellent experience working in cross-functional team-oriented environments
• Demonstrates strong project management skills
• Understanding of ICH and regulatory environment as it pertains to clinical operations
• Ability to multitask and prioritize; comfortable with changing priorities
• Excellent interpersonal, problem-solving and organizational skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives
• Proficient in reviewing and assessing clinical data
• Excellent written and oral communication skills
• Experience with Phase 1 and Phase 2 studies, rare disease and global clinical trials is a plus
• Experience in working in a small organization is preferred