Director Group Quantitative Pharmacology
Tasks
- Author regulatory briefing books
- Contribute to multi disciplinary meetings
- Deliver quantitative analyses
- Develop study reports for review
- Develop well constructed reports
- Ensure appropriate report messaging
- Ensure high quality accurate analyses
- Interact with regulatory agencies
- Interpret quantitative results
- Manage PK/PD evaluation
- Prepare CTD summaries
- Provide messaging to PMx management
- Support regulatory strategy development
Perks/Benefits
- 401k company match
- Annual bonuses
- Comprehensive benefits
- Dental insurance
- Disability insurance
- Equity awards
- Family support benefits
- Fitness Center
- Health insurance
- Life insurance
- On-site work required
- Paid leave
- Paid time off
- Vision insurance
Skills/Tech-stack
BLA authoring | CTD preparation | PD modeling | PK/PD | PK/PD Modeling | Pharmacodynamics | Pharmacokinetics | Pharmacology | Pharmacometrics | Quantitative pharmacology | Regulatory strategy | Regulatory writing
Education
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