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Director, CMC Project 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 Director, CMC Project Management who will be responsible for facilitating and coordinating the strategic planning, integration, and execution of the company’s CMC development programs across the portfolio. This position serves as a vital role within CMC, driving cross-functional alignment, integrated planning, and execution from pre-clinical development through commercial readiness. 

Reporting to the Senior Vice President of CMC, this individual will partner closely with CMC, Clinical Drug Supply, Regulatory, Quality Assurance, Finance, and Program Leadership to ensure CMC programs are aligned with corporate goals and clinical development plans. 

Responsibilities:

 

Program Management 

  • Drive the creation and ongoing management of integrated program plans, including timelines, priorities, milestones, risk registers, and action plans. 
  • Manage a portfolio of CMC projects, ensuring alignment with corporate goals and clinical development plans. 
  • Support the development of clear, data-driven scenarios and strategic options that enable agility and well-informed decision-making. 
  • Facilitate effective cross-functional team coordination, meeting management, and execution against deliverables. 
  • Ensure consistent application of project management best practices, including project plans, dashboards, timelines, risk registers, and governance. 
  • Identify, establish, and continuously improve project management processes, tools, metrics, and operating models across CMC teams to improve efficiency. 

Operational Excellence 

  • Ensure CMC project meetings and CMC governance meetings are agenda-driven and focused on efficient decision-making. 
  • Coordinate and document agenda and meeting notes for meetings with internal and external stakeholders to ensure clear communication and expectations as well as efficient execution of CMC activities and CMC governance meetings. 

Financial Management 

  • Manage the CMC project budgets to ensure accurate forecasting, alignment with strategic priorities and accountability across CMC. 
  • Facilitate the review and approval of CDMO scopes of work, purchase orders, and invoices. 

Qualifications:

  •  Bachelor’s degree (advanced degree preferred) in Chemistry, Pharmaceutics, or related field. 
  • 12+ years of experience in pharmaceutical or biotech industry, with at least 3 years of experience in CMC project management or related technical operations role or equivalent experience. 
  • Experience with small molecule and solid oral dosage form development preferred. 
  • PMP or PMI certification is beneficial but not required.  
  • Experience collaborating with CDMO partners. 
  • Demonstrated analytical, problem-solving, and scenario planning skills. 
  • Exceptional organizational and communication skills and a demonstrated ability to work independently and collaboratively across all levels of the organization. 
  • Curious, adaptable, and energizing leader adept at leading through change. 
  • Champions and models the organization’s values, fostering a culture of quality, inclusion, and continuous improvement across all teams. 
  • Proficiency with project management tools such as Smartsheet or OnePager preferred. 
  • Ability to thrive in a fast-paced, dynamic environment with shifting priorities. 

Salary Range: $210,000 – $230,000

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