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Director/Senior Director Data Management

In the three decades since the discovery of the genetic defects that cause cystic fibrosis (CF), researchers have made remarkable advances for patients. Yet the ultimate goal of CF drug development – to fully normalize the function of CFTR, the key protein leading to the pathology of CF – has remained out of reach. Sionna Therapeutics was formed in late 2019, leveraging 10 years of large pharma scientific investment and expertise. Our experienced scientific team has been on a mission to fully normalize CFTR function, and is developing a portfolio of oral small molecules to accomplish that goal. Our proprietary small molecules correctors bind to the NBD1, ICl4 and TMD1 domains of CFTR and have the potential for best-in-class efficacy. Our first NBD1 corrector, SION-638, began Phase 1 clinical trials in December 2022.

Position Summary

Sionna Therapeutics is seeking a Director/Sr. Director Data Management who will manage all aspects of the clinical trial data management process from study start up to database lock for Electronic Data Capture (EDC) trials managed in house and those contracted to Clinical Research Organizations (CROs); serves as functional leader/SME in collaboration with the VP Development Operations to define strategy for in-house data management team, resourcing plan and hiring.

The position allows for either hybrid or remote work with occasional in-person meetings in the greater Boston area as needed.  Minimal travel is required for potential meetings with partner CROs and vendors.  This position reports to the Vice President, Development Operations.

Key Responsibilities:

  • With VP Development Operations, defines strategy for in-house DM function and oversight of CRO DM vendors
  • Helps define resourcing plan for DM and leads hiring for the function; day to day management direct reports as applicable
  • Maintains knowledge of current regulatory guidances and regulations relating to DM, as well as industry best practices
  • Lead Data Management (DM) contact and contributor for assigned clinical studies
  • Supports and/or leads applicable data management activities for natural history and data sharing/use collaborations in conjunction with Clinical Development
  • Serves as an active member of Study Teams
  • Works within and across functions to manage and optimize timelines and ensure that clinical data management deadlines are met
  • Liaises with third-party vendors such as CROs and central laboratories in support of timelines and data-related deliverables
  • Responsible for working with database builders to develop EDC databases, edit checks and reports in support of the protocol and analyses
  • Develops UAT requirements for new study databases and revisions; tests according to UAT Plan
  • Create and maintain data management documentation, including development and implementation/management of in-house data review and management plan
  • Regularly review and query clinical trial data as indicated in the Data Validation Specifications
  • Help design listings and visualizations in support of clinical and medical review of data
  • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
  • Train personnel on EDC and other clinical systems, as needed
  • Coordinate with safety vendor on adverse event reconciliation
  • Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required
  • Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
  • Helps develop Data Management standards
  • Train and/or supervise the daily responsibilities of more junior staff as assigned
  • Other duties as assigned

Minimum Qualifications:

  • Bachelor’s degree or equivalent in health-related field preferred
  • 12+ years of experience in clinical data management in the pharmaceutical/biotechnology industry
  • Proficiency in the area of clinical data collection, cleaning and analysis
  • Excellent experience working in cross-functional, collaborative team-oriented environments
  • Demonstrates strong project management skills
  • Understanding of ICH and regulatory environment as it pertains to data management
  • Working knowledge of at least one EDC system (Rave preferred)
  • Understands and routinely considers how data management decisions impact other functional areas and deliverables
  • Experience in industry covering Phase I – Phase III studies in the US and ROW