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Senior Clinical Project Manager

Sionna Therapeutics is a life sciences company dedicated to developing highly effective and differentiated treatments for cystic fibrosis (CF) by normalizing the function of CFTR, the key protein associated with disease progression in CF. Building on over a decade of extensive research on the genetic mutations associated with CF and founded in 2019, Sionna is advancing a pipeline of small molecules engineered to correct the protein defects caused by ΔF508, the most common mutation that affects the CFTR protein. The company has a first-in-class portfolio of programs targeting correction of NBD1, the key and unique mechanism to enable full restoration of ΔF508-CFTR function, and complementary programs targeting ICL4 and TMD1. Sionna’s pipeline has the potential to deliver best-in-class efficacy and reach previously unachievable levels of long-term benefit for people with CF.

Position Summary

Sionna Therapeutics is seeking a Senior Clinical Project Manager (Sr. CPM) who will coordinate and help to lead functional team members, CROs and vendors to successfully deliver clinical studies in collaboration with the Director of Clinical Operations. The Sr. CPM will be responsible for providing performance metrics and helping to ensure the quality of deliverables in all assigned clinical trials.  The Sr. CPM will oversee and manage the eTMF which includes the setup of new studies.  Also, as needed, the person in this role will support and help develop and manage clinical operations SOPs, 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 some budget aspects with the internal functional leads, CRO and vendors to ensure that the overall project objectives are met
  • Initiate and build professional relationships both with clinical site staff and CRO/Vendor partners
  • Partner with the CRO to ensure robust subject enrollment and site/data monitoring strategies are developed and carried out effectively
  • Responsible for the management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), Informed Consent Forms (ICFs), confidentiality agreements
  • Responsible for helping to develop, track, review, and manage (if applicable) study related plans and processes, including Investigator agreements (CTA), clinical monitoring plan, safety monitoring plan, lab manuals, protocol deviations, etc.
  • Oversee study start-up and ensure all startup activities, including site selection and activations are aligned with internal timelines
  • Manage and work with translation vendor to prepare clinical, subject-facing documents for IRB/EC submissions
  • Oversee monitoring activities, perform site monitoring and co-monitoring visits as needed; review of monitoring visit reports from the CRO
  • Participate in data review and query management
  • Perform UAT of clinical databases
  • Responsible for oversight and maintenance of the TMF by ensuring SOPs and TMF plans are being followed
  • Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices.
  • 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
  • Hep mentor and train more junior members of the clinical team in the area of clinical operations
  • Ensure compliance of clinical trials with national and international regulatory requirements
  • Help to ensure studies are “inspection ready” at all times
  • Support and help to drive the development, review, approval, training 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 time in clinical operations; additional time in other study site-facing operational capacities a plus
  • Solid understanding of clinical development process from IND approval to NDA 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 and data management
  • 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 in early phase, rare disease and global clinical trials is a plus
  • Experience in other study site-facing operational capacities is a plus
  • Experience in working in a small organization is preferred