Senior Scientist – DMPK (Project Style)
HireMinds is working with a rare disease and biologic focused Biopharmaceutical company local to Cambridge and helping in their search for a project style DMPK expert. In this role you will be responsible for providing DMPK and PK/PD analysis to project teams in helping guide multiple drug discovery and development programs through the drug discovery and clinical pipeline. You will also contribute to PK reports and author relevant sections of preclinical and clinical protocols, and corresponding Regulatory filings. You will work cross-functionally with peers in a variety of Research, Preclinical, and Clinical facing disciplines in providing expertise in clinical dose regimens for novel therapeutics in the biologics, gene therapy, and rare disease space. You will be relied upon to convey key DMPK insight to teams ranging from discovery to clinical stages so effective communication is a key asset in this role in order to be effective. If you want to be part of this intimate team which guides the greater organization reach out to Christina Pentikis on the HireMinds team.
- You will need past project experience as a DMPK team representative on discovery, early, and clinical stage projects. Communication is key as you'll work with a variety of team members as the DMPK and PK/PD expert on programs.
- You will be adept at generation of quantitative/systems pharmacology, PK, PBPK and PK/PD modeling and simulation to support candidate nomination
- You will be responsible for guidance to teams on clinical dose projections and contribute to design of clinical protocols
- You will work in overseeing in-house and external CRO studies in producing study data
- You must have experience with Pharmacokinetic and Pharmacodynamic analysis and be able to provide updates to project teams and when needed with relevant regulatory representatives
- Ph.D in drug metabolism, pharmacology, or pharmacokinetics with 5+ years of Biotech or Pharmaceutical industry experience
- Experience pharmacokinetic/pharmacodynamic (PK/PD) software: Phoenix WinNonlin, SimCYP, and SimBiology-MATLAB
- You will have a track record of devising and implementing PK/PD assessments and contributions in drug development setting
- Experience with gene therapy or biologic drug development is preferred
- A proven track record of publications and presentations are required
- Ability to be a team player and respond to colleagues requests in broad range of stages of the drug development process is key