£0 per year
26 days ago
This position is for an Associate Director, DMPK within the Nonclinical Development and Safety Department of an innovative and growing clinical stage small molecule biotech focussed in immunology and fibrosis. You will be the comapny DMPK lead, identifying critical ADME/PK needs and devising the DMPK/ADME strategy while representing DMPK on interdisciplinary project teams ensuring ADME, PK, bioanalytical and PK/PD application. You will also closely manage CROs relationships.
- Serve as the DMPK representative across early discovery and late stage clinical teams
- Identify critical ADME/PK needs
- Analyze and interpret in vitro/in vivo data, providing project teams with risk assessments and issue management, and support of clinical study protocol development for human safety and efficacy trials
- Solve project ADME-related issues
- Manage external CROs for the design and execution of in vitro/in vivo ADME, PK and bioanalytical studies
- Develop novel in vitro assays and animal studies to solve challenge ADME issues of drug candidates.
SKILLS & REQUIREMENTS:
- Ph.D. in a related field with ≥5 years of relevant industry experience in a drug discovery and development environment
- Proven knowledge in ADME, PK and bioanalytics.
- Capable of working independently within a highly matrixed environment and to be able to provide cross-functional support for development teams.
- Excellent organizational, interpersonal and verbal/written communication skills
- Knowledge or experience in radiolabeled studies, PBPK, PK/PD modeling or drug transporter is a preferred