Key responsibilities:
- Bring strong AI and digital fluency; use enterprise tools to advance strategic, scientific, and operational leadership in clinical pharmacology.
- Identify, develop, and implement high-value AI use cases to improve clinical pharmacology planning, analyses, and decision quality.
- Represent PK Sciences in project teams; collaborate with internal stakeholders and, as appropriate, regulatory agencies.
- Provide expert pharmacokinetic/drug metabolism and clinical pharmacology input to develop drug candidates across the Research Development and Commercial continuum.
- Use AI to accelerate understanding of nonclinical/clinical PK/PD relationships, development dosing strategies, and predictions.
- Champion AI to accelerate delivery of study protocol/report/project summary/development plan components, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND/IMPDs and NDA/BLAs; prepare responses to Health Authority questions.
- Drive interdisciplinary collaboration among PK disciplines, Drug Disposition (ADME, BA), Modeling & Simulation (M&S), via PK sub-teams.
- Collaborate with clinicians and clinical development teams to integrate PKS insights into study design, data interpretation, and decision-making.
- Model AI/ML approaches for model-guided molecular design, data automation, and authoring regulatory documents.
Essential requirements:
- Ph.D./Pharm.D. with relevant experience in clinical pharmacology, drug metabolism, and pharmacokinetics (or related).
- 0β2 years drug discovery and/or development (academia, CRO, biotech, or Pharma).
- 2+ years experience (lead) overseeing ADME/DMPK project strategy in clinical development, or AI strategy (Principal Scientist II); 4+ years for Senior Principal Scientist.
- Deep knowledge of pharmacokinetics, drug metabolism, and PK/PD evaluation; experience working on (preferably global) project teams; awareness of drug development and regulatory sciences.
- Experience in cross-functional, matrixed environments.
- Strong oral and written communication skills.
Desirable requirements:
- Hands-on project experience applying AI to clinical pharmacology topics.
Application instructions:
- Not provided in the job description.