Senior Director, Data Science
USA - New Jersey - Rahway, United States
USD 210K-331K Senior-level Full Time
Tasks
- Align modeling strategies with regulatory expectations
- Author and review INDs CSRs CTD modules NDA BLA submissions
- Deliver clinical pharmacology and pharmacometric analyses and reports
- Develop and implement MIDD strategies
- Integrate quantitative insights into development strategies
- Lead mentor and develop QP2 scientists
- Lead quantitative pharmacology strategy
- Provide scientific and operational oversight
- Represent company with regulatory agencies and conferences
- Serve as QP2 lead on assigned programs
- Support due diligence for business development
- Translate nonclinical findings into clinical plans
Perks/Benefits
- N/A
Skills/Tech-stack
Artificial Intelligence | Biopharmaceutics | Clinical Pharmacology | Data Engineering | Data Modeling | Data Visualization | Database Design | Drug development | Due Diligence | Immunoassays | Immunotherapy | MIDD | Machine Learning | Model-informed drug development | Oncology | Pharmacodynamics | Pharmacokinetics | Pharmacometric Modeling | Quantitative systems | Quantitative systems pharmacology | Regulatory strategy | Software development | Systems pharmacology | Translational medicine | Waterfall model
Education
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