DMPK Project Leader

1 week ago

Cambridge, Massachusetts, United States Beacon Hill Full time
DMPK Project Leader

Beacon Hill is seeking a highly skilled DMPK Project Leader to join our team. As a key member of our discovery team, you will be responsible for leading cross-functional teams and providing technical and scientific expertise for ADME profiling and interpretation of data.

Key Responsibilities:

  • Represent the DMPK function on cross-functional discovery teams and provide technical and scientific expertise for ADME profiling and interpretation of data.
  • Define strategy for in vitro/in vivo DMPK and DDI risk assessment for drug candidates.
  • Strategically design and lead ADME/PK studies, critically analyze and interpret data, identify issues, and help overcome technical challenges.
  • Coordinate and interact with matrix project team members for planning and executing DMPK-related activities.
  • Collaborate with PK/PD modelers to establish PK/PD correlations and guide preclinical study design.
  • Contribute to the selection of preclinical tox species and toxicokinetic plan to support IND.
  • Support human dose projections based on preclinical data to guide candidate selection.
  • Author ADME/DMPK sections of regulatory documents (e.g., IND/IB).
  • Contribute to the development of functional processes and procedures focused on CRO interactions and organizational efficiency.
  • Conduct scientific presentations to senior management, project teams, and internal/external collaborators.
  • Provide operational oversight for quality and performance of DMPK activities, including interactions with CROs and external project support.
  • Contribute to the selection and qualification of CROs and vendors.
  • Closely interact with key internal stakeholders and ecosystem companies.

Basic Qualifications:

  • Ph.D. in pharmaceutical science, biochemistry, or related scientific discipline with 7+ years or MS/BS with 10+ years of relevant experience.
  • 5+ years experience leading representing DMPK function on project teams, particularly in discovery and early development is required.
  • Extensive knowledge of drug metabolism, PK, and relevant analytical techniques is required.
  • Strong understanding of small molecule drug discovery workflow is required; understanding of biologics/novel modalities is desirable.
  • Hands on experience conducting, troubleshooting, and summarizing in vitro and in vivo ADME/DMPK studies is required.
  • Familiarity with regulatory guidelines and requirements related to DMPK in drug development is desirable.
  • Demonstrated DMPK skills through high quality peer-reviewed publications is desirable.
  • Experience in outsourcing and external oversight of nonclinical DMPK/ADME studies is desirable.
  • Attention to detail and quality are critical to success.
  • Excellent communication skills including interpersonal skills and data presentation skills.
  • Demonstrated ability to adapt to a fast-paced and dynamic work environment.
  • Demonstrated ability to successfully work in cross-functional teams with an emphasis on teamwork, collaboration, and communication within team and across the department.
  • Forward thinking mindset with demonstrated ability to manage multiple projects and identify and resolve issues.

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