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Senior Director, Clinical Pharmacology Scientist

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 Senior Director, Clinical Pharmacology Scientist who is responsible for clinical pharmacology protocol design, scientific data review and interpretation to support to the company’s programs. This role will include, but not be limited to, utilizing PK and PD approaches, reviewing and interpreting study data and helping to ensure that clinical pharmacology studies follow GCP and regulatory policies. The position allows for either hybrid or remote work with occasional in-person meetings in the greater Boston area as needed. Minimal travel is required for potential meetings with partner CROs and vendors. This position reports to the Vice President, Development Operations.

Responsibilities:

  • In collaboration with Sionna’s Clinical Pharmacology consultant, act as the lead clinical pharmacologist on Clinical Pharmacology study teams: Support or lea, 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

Qualifications:

  • 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
  • Experience working with an external CRO is desirable

Salary Range: $250,000 – $300,000

Apply now