Goldfinch Bio

Job Title: Senior Director, Clinical Pharmacology

Job Number: 23815

Location: Cambridge, MA

Job Description

The Role: Goldfinch Bio seeks a highly motivated and qualified individual for the position of Senior Director, Clinical Pharmacology. This role reports to the Vice President, Translational & Clinical Nephrology, and has matrixed responsibilities to a cross-functional team. The Senior Director, Clinical Pharmacology will be primarily responsible for the timely development and implementation of clinical pharmacology and pharmacometric strategy plans across multiple drug candidates and indications, as well as the interpretation of non-clinical and clinical study results. The Senior Director, Clinical Pharmacology will act as a primary driver for each of our program’s clinical pharmacology plans and contribute significantly to their operational successes.

Responsibilities

  • Act as the lead clinical pharmacologist for one or more clinical stage programs
  • Independently formulate clinical pharmacology strategy to support regulatory submissions (e.g. IND, NDA, BLA)
  • Work in close partnership with Medical, Regulatory, Clinical Operations, Biostatistics and Translational Medicine to advance these programs from Phase I to late-stage development
  • Responsible for designing and implementing dose-finding strategies to ensure optimal dose and dosing regimens in clinical trials
  • Draft clinical pharmacology components of protocols, investigator’s brochures, and other regulatory documents
  • Oversee the design and protocol writing of clinical pharmacology studies (e.g. food effect, human ADME, drug interactions, QTc, renal and hepatic impairment, etc.)
  • Manage external vendors to perform PK and PK/PD analysis and integrate this knowledge into the overall clinical program
  • Responsible for pharmacometric strategy, including QSP, MBMA, PK/PD, population PK, exposure-response, and longitudinal disease progression modeling
  • Responsible for translational modeling (model-based drug development) of non-clinical and clinical data 

Required Skills

  • Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences or related disciplines
  • Advanced capabilities in multiple pharmacometric methods required (QSP, MBMA, Population PK, PK/PD, exposure response)
  • Strong technical proficiency in PK analysis (NCA)
  • Experience with common PK and pharmacometric software (WinNonlin, NONMEM, R)
  • 7+ years’ experience in Clinical Pharmacology
  • Strong understanding of clinical pharmacokinetic concepts
  • Regulatory filing experience
  • Strong knowledge of DMPK and Toxicology Preferred
  • Effective verbal and written communication skills
  • Experience in renal indications preferred
  • Experience in small and large molecules preferred

 

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