Senior Director, Quantitative Pharmacology
Tasks
- Coordinate cross functional studies with toxicology DMPK bioanalytical and biomarker teams
- Develop and communicate clinical pharmacology strategy across clinical development
- Integrate PK and PK PD insights into dose selection and study design
- Lead development of clinical pharmacology sections for regulatory filings
- Oversee clinical pharmacology deliverables for pre IND IND phase 1 to 3 activities
- Provide go no go recommendations for business development opportunities
- Provide input to model based drug development strategies
- Review and approve clinical study protocols and study design
- Support biomarker development and incorporation into early phase studies
- Train and mentor junior scientists and manage team development
Perks/Benefits
Skills/Tech-stack
Assay Development | Bioanalytical Assay | Bioanalytical assay development | Biomarker development | Clinical Pharmacology | Clinical study | Clinical study protocols | Clinical trial | Clinical trial management | Dose selection | Drug development | Exposure-response | Exposure-response analysis | Model-Based Drug Development | PD modeling | PK/PD | PK/PD Modeling | Pharmacodynamics | Pharmacogenomics | Pharmacokinetics | Pharmacometric Modeling | Regulatory Submissions | Response analysis | SOP Development | Study design | Study protocols | Trial management
Education
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