DMPK Project Representative

2 weeks ago

San Diego, California, United States Vividion Therapeutics Full time
Job Summary

The DMPK Project Representative will play a crucial role in representing the Drug Metabolism and Pharmacokinetics (DMPK) functional area on multidisciplinary project teams. This position involves providing scientific and strategic input, leading and innovating in a team environment, and overseeing DMPK studies to support the preclinical and clinical development of the company's portfolio.

Key Responsibilities
  • Represent DMPK functional area on multidisciplinary project teams
  • Lead DMPK studies supporting preclinical and clinical development
  • Design, execute, and manage PK, PK-PD, and drug metabolism studies
  • Collaborate with medicinal chemists to optimize drug candidates
  • Integrate ADME, PK, and PK/PD endpoints with discovery biology data
  • Lead and manage in-vivo and in-vitro ADME/PK studies
  • Conduct PK and PK/PD modeling and predict human PK and efficacious dose projections
  • Evaluate and interpret DMPK data and design studies to address project issues
  • Prepare data summaries and present results to various stakeholders
  • Contribute to nonclinical PK/ADME documents for regulatory submissions
  • Prepare regulatory submission documentation and author relevant sections
  • Mentor and motivate the in-house DMPK team
  • Manage interactions with CROs to ensure quality and timely execution of DMPK studies
Requirements
  • PhD in Biochemistry, Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, or related discipline with 2+ years of experience in the industry; or MS with 5+ years of experience; or BS with 10+ years of experience
  • Expertise in pharmacokinetics of small and/or large molecules, modelling, drug metabolism, in vitro enzyme kinetics, and LC/MS bioanalytical methodology
  • Experience in designing and executing PK and PK/PD studies
  • Experience in nonclinical PK/ADME document preparation for regulatory submissions
  • Proficiency with Phoenix WinNonlin, Excel, and Prism software
  • Familiarity with PBPK modeling is a plus
Core Competencies
  • Excellent written and verbal technical communication skills
  • Ability to lead, guide, and influence teams in decision-making
  • Collaborative team behaviors and ability to build and sustain relationships with R&D customers and the wider scientific community
  • Ability to work autonomously and collaboratively in a multidisciplinary team setting
  • Passion for data-driven analysis and strong business-of-science thinking
  • Ability to thrive in a fast-paced, highly matrixed environment
  • Strong understanding of DMPK, PK/PD modeling, human PK, and DDI prediction strategies
  • Proven track record of leading studies to enable IND filing and contributions to drug discovery
  • Ability to apply quantitative skills for model-based drug development and complex issue resolution
  • Proficiency in managing CROs and robust knowledge of relevant regulatory guidance
What We Offer

In addition to a competitive compensation package with long-term incentives and 401k match, Vividion also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life, and disability insurance.

Vividion Therapeutics, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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