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 Director, Clinical Development (Medical Director) to join the Clinical Development team and report to the Senior Director, Head of Clinical Development MDs. This individual will support the design, execution, and medical oversight of clinical studies across Sionna’s growing portfolio. The Medical Director will serve as a study medical monitor for selected trials, contribute to clinical development strategy, provide clinical and scientific input across development functions, and support safety evaluation activities under the guidance of the Senior Director and Chief Medical Officer. The Director will have the opportunity to grow and learn every day from leading experts across Sionna’s functions, in a fast-paced and high-performing biotech environment.

The Director will bring industry experience on clinical studies and program teams, a track record of successful execution and oversight of clinical trial components (e.g., protocol development, medical trial oversight, clinical data review and interpretation), a strong understanding of clinical trial safety oversight, experience with regulatory submissions and interactions, and a background of relevant clinical experience. The position is based in the greater Boston area, with the opportunity to craft a flexible hybrid work schedule including in-person and remote work as part of Sionna’s Flexible First workforce strategy.

Responsibilities:

• Serve as medical monitor for assigned clinical trials, providing ongoing medical oversight including review of safety data, eligibility assessments, medical queries, and protocol deviations.
• Collaborate with cross-functional study teams to support successful study execution, data integrity, and subject safety.
• Participate in the review and interpretation of clinical data, contributing to safety reviews, data listings review, and preparation of key study documents.
• Contribute to and/or serve as the lead for the development of clinical protocols, amendments, study designs, IBs, and other clinical and scientific documents.
• Assist in the development of clinical components of development plans in alignment with project strategy.
• Provide clinical expertise to internal stakeholders and external partners.
• Support safety oversight activities under the direction of the Senior Director.
• Review safety reports, SAEs, and aggregate data summaries; contribute to safety narratives and regulatory safety submissions.
• Participate in and/or serve as the lead in the preparation and review of regulatory documents including INDs/CTAs, briefing documents, and clinical sections of regulatory responses.
• Support preparation and delivery of internal and external clinical data presentations and publications.
• Adhere to GCP, ICH guidelines, and internal SOPs.
• Contribute input to clinical-related SOPs and quality processes as needed.

Qualifications:

• MD or equivalent with 2–4 years of industry experience in a Clinical Development or medical monitoring role.
• 5+ years of clinical practice experience; pulmonary or rare disease subspecialty highly desirable.
• Hands-on experience as a clinical trial medical monitor.
• Experience supporting or contributing to regulatory submissions.
• Strong working knowledge of GCP and ICH guidelines.
• Ability to work collaboratively across diverse teams.
• Excellent communication, analytical, and organizational skills.
• Willingness to travel a few times yearly to key events such as major medical conferences, investigator meetings.