Careers

Director, DMPK at Decibel Therapeutics
Boston, MA, US

Position Overview & Responsibilities

Decibel is seeking a Director of DMPK who will be responsible for:

  • Providing DMPK expertise on multi-disciplinary drug discovery and development teams
  • Guiding discovery project teams toward clinical candidate selection, developing and driving DMPK strategies for lead optimization and solving ADME issues, designing in vitro and in vivo DMPK studies and interpreting results
  • Taking ownership of design, execution and interpretation of critical studies as well as creation of high-quality documents supporting regulatory filings
  • Applying modeling approaches (in silico, PK, PBPK) to support human pharmacokinetics, dose predictions and quantitative risk assessment of drug-drug interactions, conducting PK/PD modeling, monitoring of GLP bioanalysis
  • Managing direct reports and CRO partners
  • The candidate will be required to generate, analyze and present data, both orally and as written reports, delivering presentations internally or externally as needed
  • Ability to travel periodically, including internationally, to develop and foster collaborations with CRO partners

Requirements

  • PhD in Pharmacokinetics, Pharmaceutical Sciences, or related field with a minimum of 12 years of relevant industry experience in NCE ADME and pharmacokinetics is required
  • Proven track record of supporting drug discovery and development programs as DMPK project representative on multifunctional project teams is required
  • Extensive experience interfacing with, and providing scientific guidance to, CRO partners and proven ability to work efficiently in a hybrid model
  • Extensive understanding of DMPK principles, with broad expertise in small molecule drug metabolism, transporter, pharmacokinetics and bioanalysis is required
  • Extensive experience in setting up LC-MS based bioanalytic methods
  • Proven skills in pharmacokinetic modeling, including application of SimCyp and/or Gastroplus PBPK, Phoenix WinNonlin, and/or NONMEM are preferred
  • Knowledge of GLP, development and regulatory guidelines and filings is required
  • The ability to work independently, excellent interpersonal, organizational, oral/written communication and teamwork skills, ability to multi task and prioritize to deliver results within tight timelines are required
  • Previous people management experience is required
  • A track record of communicating scientific concepts and strategies effectively, including publication record in top-tier, peer reviewed journals, and authoring regulatory filings

Additional Desirable Experience

  • Previous experience with local delivery modalities is a plus
  • Substantial knowledge of NBE ADME and DMPK would be an asset

People