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Sionna Therapeutics · 17 hours ago

Director, Clinical Development MD

Waltham,MA,US

Full-time

Hybrid

Lead/Staff, Director/Executive

$220K/yr - $250K/yr

5+ years exp

Sionna Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel medicines for cystic fibrosis. The Director, Clinical Development will oversee clinical studies, contribute to development strategy, and ensure safety evaluation while collaborating with cross-functional teams.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics

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

Qualification

MDEquivalentClinical Development experienceMedical monitoring experienceRegulatory submissions experienceGCPICH guidelinesPulmonary disease knowledgeAnalytical skillsCommunication skillsOrganizational skillsCollaborative teamwork