Represent the DMPK function on cross-functional discovery teams and provide technical and scientific expertise for ADME profiling and interpretation of the 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 wit 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.