Sionna Therapeutics · 20 hours ago
Senior Director, Clinical Pharmacology Scientist
Greater Boston
Full-time
Hybrid
Director/Executive
$250K/yr - $300K/yr
8+ years expSionna Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel medicines for cystic fibrosis. The Senior Director, Clinical Pharmacology Scientist will lead clinical pharmacology protocol design and data interpretation to support the company's programs, ensuring compliance with GCP and regulatory policies.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
Hiring Manager
Roxanne McGrath
Responsibilities
In collaboration with Sionna’s Clinical Pharmacology consultant, act as the lead clinical pharmacologist on Clinical Pharmacology study teams: Support or lead, protocol design and development, oversight of execution, analysis, and reporting of Clinical Pharmacology studies (e.g., food effect, human ADME, DDI, QTc, renal, and hepatic impairment trials)
Work in close partnership with Medical, Regulatory, Clinical Operations, Data Management, Biostats, and DMPK teams from Phase I to late-stage development
Participate in the authoring and reviewing of additional core study documents, including IBs, ICFs, CRFs, SMPs, SAP, TLFs and CSRs
With the Medical Monitor, review and monitor emerging clinical and nonclinical safety and efficacy data, and develop sound, strategic solutions to study and program issues; collaborate with the clinical team to ensure issue resolution
In partnership with the Clinical Development team, review, analyze, and interpret individual participant data and study results for clinical pharmacology studies and later phase studies
Interpret and present results to the Program Team, and to Senior Leadership Team, in collaboration with the Program Team, if necessary
Support clinical pharmacology outsourcing process; Partner and manage relationships with external vendors/ contractors, where needed
Contribute to regulatory submissions and health authority agency interactions relevant to clinical pharmacology including but not limited to pre-meeting briefing packages, queries and information requests, review of regulatory documents and label discussions
Review clinical pharmacology reports and ensure documentation is properly archived
Keep up-to-date knowledge of model-informed drug development (MIDD) with focus on clinical pharmacology, biopharmaceutics, PKPD & other related new quantitative sciences
Qualification
Required
Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines preferred
8+ years of industry clinical research experience, with a demonstrated ability to interpret clinical and translational data
Strong understanding of population modeling and simulations; experience managing outsourced analyses, including population PK modeling, PK-PD modeling, and simulation to support dose selection, and exposure-response analyses
Experience writing IND, NDA/BLA, global regulatory filing sections related to clinical pharmacology and pharmacology
Thorough understanding of the drug development process from pre-IND through registration and post-registration
Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols
Strong written, verbal, and interpersonal communications skills, including ability to communicate scientific information clearly and effectively
Ability to work effectively with cross-functional groups while operating in a fast-paced, evolving environment
Ability to work independently and to organize priorities and deliverables
Preferred
Experience working with an external CRO is desirable
Company
Sionna Therapeutics
Sionna Therapeutics is developing novel small molecule therapies to treat cystic fibrosis (CF).
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$292MKey Investors
Enavate SciencesOrbiMed
2025-02-07IPO
2024-03-06Series C· $182M
2022-04-19Series B· $110M
Leadership Team
Michael Cloonan
President and Chief Executive Officer
Greg Hurlbut
Co-founder and SVP Head of Research
Recent News
2026-01-06
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2025-12-22
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2025-11-28
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