Director of Clinical Pharmacology
Isomorphic LabsVisit Isomorphic Labs website
AI-first drug design and development company building a unified drug-design engine to advance new medicines.
London, United Kingdom
Funding history
Investors
About Isomorphic Labs
Isomorphic Labs uses predictive and generative AI models, computational biology, and drug-design expertise to develop therapeutics across partnered and internal programs.
Skills
Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
About the Role
You will lead clinical pharmacology, bioanalysis, and modeling strategies for small-molecule oncology and non-oncology programs. You will oversee CROs, design clinical pharmacology components of Phase 1 and 2 studies, analyze PK data, develop dose recommendations, support regulatory submissions, and apply predictive AI tools.
Requirements
- Ph.D. or Pharm.D. in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline
- 8+ years of relevant biopharmaceutical industry experience
- Expertise in oncology and non-oncology drug development
- Experience translating in-vitro and in-vivo data into human PK and dose predictions
- Experience with NONMEM, GastroPlus, or Simcyp
- Experience managing CROs and external vendors
- Experience authoring IND and NDA clinical pharmacology submissions
- Experience interacting with FDA and EMA
Responsibilities
- Design and execute clinical pharmacology, bioanalysis, and modeling strategies
- Oversee global CROs and clinical pharmacology studies
- Lead clinical pharmacology components of Phase 1 and 2 protocols
- Analyze and report bioanalytical PK and human AME data
- Use modeling to optimize doses and select RP2D
- Author and review clinical pharmacology sections of regulatory documents
- Represent the company in regulatory authority meetings
- Develop human PK and translational capabilities
- Use PK modeling and allometric scaling to predict human dose and exposure
- Provide strategic input for candidate selection and First-in-Human trials
- Apply predictive AI models for human PK and DDI analysis