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Senior Director, Clinical Pharmacology

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 who is responsible for clinical pharmacology protocol design, scientific data review and interpretation and clinical pharmacology to support to the company’s programs, including but not limited to utilizing pharmacometrics 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:

  • Serve as the subject matter expert on clinical pharmacology activities for the company’s programs
  • In collaboration with Sionna’s Clinical Pharmacology consultant, act as the lead clinical pharmacologist on Clinical Pharmacology study teams: Support or lead the design, protocol 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 drafting and reviewing of additional core study documents, including IBs, ICFs, CRFs, SMPs, SAP, TLFs and CSRs
  • With the Medical Monitor, review, monitor and interpret emerging safety and efficacy nonclinical and clinical data and develop sound, strategic solutions to study and program issues; collaborate with the clinical team to ensure issue resolution
  • Collaborate with the clinical development team on the review, analysis, and interpretation of 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 Management Team, in collaboration with the Program Team, if necessary
  • Partner with external vendors/ contractors
  • 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
  • Perform hands-on population-based PK/PD model analyses for both clinical data and non-clinical data, modeling non-clinical data for human translation purposes, where needed
  • Document and archive study files properly and write or review clinical pharmacology reports
  • Perform hands-on exposure-response (correlation) analyses using statistical approaches, such as logistic analysis, survival analysis
  • Support clinical pharmacology outsourcing process
  • 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
  • 10+ years of industry clinical research experience, with a demonstrated ability to interpret clinical and translational data
  • Experience in population modeling and simulations; manage analysis, including population PK modeling, PK-PD modeling, and simulation to support dose selection, exposure-response, and exposure-safety 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 – $290,000

Apply now