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Senior Manager/Associate Director, IT – Business Partner & Solutions Lead, Quality & Enterprise Content Management

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 Business Partner and Solutions Lead to evolve Sionna’s core enterprise content management approach in supporting Quality, GXP, and structured content as Sionna grows and progresses as a clinical-stage biotech.  S/he will be responsible for implementing within Sionna’s defined enterprise architecture, and with full alignment and operating as part of enterprise services and operations.

The successful candidate will have experience in building, managing, and scaling IT operations within early-stage BioPharma/Biotech organizations that are emerging from early discovery and transitioning to an integrated R&D enterprise.  S/he will need to be hands-on and have high acumen in a heavily partner/vendor/service management model.  S/he will possess strong leadership, management, and communication skills, ensuring that matrixed team members understand and respect functional goals, objectives, priorities, and timelines.

We are accepting resumes for the position at careers@sionnatx.com.

Key Responsibilities:

  • Function as an internal advisor and business partner on business processes, technologies, and system applications.  Will be primary business partner for Sionna’s enterprise content management for quality, GxP, and other structured content.
  • Develop, implement, and enable the IT services and capabilities with those key business partners, bringing technology perspective to understand what’s possible, and collaborating across teams to drive needed business outcomes.
  • Partner with business functions to develop and implement structure enterprise content operational policies and procedures for IT.
  • Execute on the IT strategy and framework for the organization where we are focused on optimizing a full cloud-first, near zero footprint model, with SaaS, cloud-based focus for applications, communications, data security and disaster recovery.
  • Provide back-up oversight and support where needed for enterprise-level software such as ERP, Applicant Tracking Systems, Agreement management systems etc. for non-scientific (Finance, HR, Legal, etc.) and scientific teams.
  • Interface with Sionna Enterprise IT Operations services to ensure seamless business facing operational/integration of structured enterprise content support.
  • Ensure solutions meet security-compliance and are compliant with all applicable regulations, including GxP and SOX requirements, partnering with Sionna Quality
  • Support IT operational planning to achieve business goals by fostering innovation, prioritizing IT initiatives, and coordinating the evaluation, deployment, and management of current and future Enterprise IT and business systems across the organization.
  • Communicate on IT-Business Outcomes
  • Act as a catalyst for change and innovation.

Minimum Qualifications:  

  • Implementation and development experience with one or more structured enterprise content management capabilities; preferably with direct experience and expertise in a BioPharma Quality & R&D specific implementation (e.g. Veeva Vault Life Sciences, Egnyte for Life Sciences, or other similar)
  • 5-10+ years’ experience working in environment that heavily utilizes external IT providers, both for Managed Services (MSP) and as project delivery teams
  • Biotech, pharma, or life sciences experience with pre-clinical, manufacturing and lab as well as an understanding of what is required in a GxP environment.
  • Advanced knowledge on Cloud-based infrastructure architecture and services (e.g. Azure, Google, AWS natively enabled full virtual underlying infrastructure).
  • Practical application and knowledge in Identity and Access Management (IAM) models, tools, and enablement in pure cloud IAM infrastructure services (e.g. native Azure with SCIM, similar Okta services and push groups, etc.)
  • Experience with IT Operating Model(s) or ITSM, preferably grounded in an ITIL based framework, with experience in any of the ITIL-based operational service applications.
  • Demonstrated experience with at least one or more of any of the standard IT Security frameworks (e.g. OSSI, ISO2700, NIST based, CIS, HITTRUST, etc.)
  • Technical integration experience with enterprise and infrastructure operations
  • Awareness and working knowledge of Part 11 compliance and cybersecurity experience is a must.
  • Ability to communicate ideas in both technical and user-friendly language with the demonstrated ability to teach and share knowledge with others in a clear and concise manner; along with the ability to communicate complex technical information to both small and large groups and to handle questions in a commercially astute and sensitive manner.
  • Strong supervisory and leadership skills
  • Exemplary client service attitude with focus on responsiveness and willingness to deliver to coworkers and customers.
  • Strong strategic, analytical, and problem-solving skills
  • Ability to establish immediate credibility among peers — a professional who is respected for intelligence and technical expertise.
  • Excellent organizational skills and attention to detail
  • Successful operating under minimal supervision and direction in a complex environment
  • Ability to communicate ideas in both technical and user-friendly language with the demonstrated ability to teach and share knowledge with others in a clear and concise manner.