Senior Director, Quantitative Pharmacology
Tasks
- Collaborate with pharmacometrics for model based drug development
- Conduct go no go recommendations for business opportunities
- Develop and approve regulatory submissions sections
- Lead SOP and working process development
- Lead clinical pharmacology strategy and dose selection
- Mentor and train junior scientists
- Oversee clinical pharmacology deliverables for clinical development stages
- Oversee cross functional studies including first in human
- Perform PK and PKPD data analysis
- Provide input to clinical development strategy
- Review and approve clinical study protocols and designs
- Support biomarker development and incorporation into studies
Perks/Benefits
- 401k match
- Dental insurance
- Flexible time off
- Medical insurance
- Paid Holidays
- Paid leave
- Student loan assistance
- Tuition reimbursement
- Vision insurance
Skills/Tech-stack
BLA | Bioanalytical Assay | Biomarker development | Biopharmaceutics | Clinical Pharmacology | Dose selection | Drug Interaction Studies | Drug Metabolism | Drug development | Drug interaction | Exposure-response | IND | Investigator Brochure | Model-Based Drug Development | NDA | PKPD Modeling | Pediatric Development | Pharmacodynamics | Pharmacogenomics | Pharmacokinetics | Phoenix NLME | Regulatory Submissions | SOP Development
Education
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