Senior Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology
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
- Collaborate with cross-functional teams
- Contribute to due diligence for licensing opportunities
- Deliver clinical pharmacology and pharmacometrics reports
- Develop and implement MIDD strategies
- Develop regulatory strategies
- Ensure high-quality, timely deliverables
- Integrate quantitative insights into development strategy
- Lead and mentor QP2 scientists
- Lead quantitative pharmacology strategy
- Manage hiring retention performance
- Oversee translational PK PD strategy
- Partner with preclinical teams for translation
- Provide scientific and operational oversight
- Represent company with regulatory agencies and scientific conferences
Perks/Benefits
- 401k
- Compassionate leave
- Dental insurance
- Healthcare insurance
- Long-term incentive
- Paid Holidays
- Retirement benefits
- Sick leave
- Vacation
- Vision insurance
Skills/Tech-stack
Artificial Intelligence | BLA | Biomarker driven dose selection | Biostatistics | CSR | CTD | Clinical Development | Clinical Pharmacology | Dose selection | Drug development | IND | MIDD | Machine Learning | Mechanistic modeling | Model-informed drug development | NDA | Oncology drug development | PD modeling | PK/PD | PK/PD Modeling | Pharmacodynamics | Pharmacokinetics | Pharmacometrics | QSP | Quantitative systems | Quantitative systems pharmacology | Regulatory Interactions | Regulatory strategy | Statistical Analysis | Systems pharmacology | Translational Pharmacokinetics | Trial design
Education
Roles
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