Associate Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (QP2‐IO)
$156,900–$247,000 year
HybridRahway, New Jersey, United States
Job Summary
Lead oncology quantitative pharmacology and pharmacometrics by framing critical questions for model-based analyses and executing translational PK/PD, population pharmacokinetic, exposure-response, and quantitative systems pharmacology (QSP) modeling. Strategize and execute tumor size and survival endpoint modeling using proportional hazards approaches while maintaining regulatory expertise for INDs, CSRs, and CTDs. Collaborate with cross-functional teams, external vendors, and partners to develop novel chemical entities and drive pipeline impact through aligned quantitative frameworks. Serve as the expert QP2-IO representative on clinical development teams from post-PCC through registration.
Required Qualifications
- Ph.D. with at least 3 years of experience
- PharmD or MS or equivalent degree with preferably 5-7 years of relevant experience
- Demonstrated impactful experience with applications of pharmacometrics methods
- Skills in experimental design
- Mathematical problem solving
- Critical data analysis/interpretation
- Statistics
- Proficiency in R, NONMEM or other similar programming language
- Professional working proficiency in written and verbal communication
- Valid Driving License
Desired Qualifications
- NONMEM
- Oncology
- Oncology Drug Development
- Phoenix WinNonlin
- PKPD Modeling
- Population Pharmacokinetics
- Regulatory Writing
- Machine Learning (ML)
- Model Driven Development
- Modeling Simulations
- Modeling Software
- Pharmaceutical Development
- Pharmacometrics
- Stakeholder Relationship Management
- Clinical Development
- Clinical Pharmacology
- Dose Response Analysis
- Drug Development
- Quantitative Pharmacology and Pharmacometrics
- Immuno-Oncology
- Quantitative Systems Pharmacology (QSP) modeling
- Comparator modeling
- Strategies for quantitative analyses
- Translational PK/PD approaches
- Population pharmacokinetic models
- Exposure-response models
- Clinical trial simulation
- Disease progression models
- Modeling of tumor size and survival endpoints including proportional hazards models
- Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology
- Authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs))
- Representing QP2-IO at regulatory meetings
- Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling
- Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models
- Collaborating within QP2-IO and with other functional areas, as well as with external vendors and partners
- Creating an aligned, quantitative framework to impact strategies and decisions on drug development teams
- Working closely with teams of highly collaborative, cross-functional scientists
- Contributing to development of novel chemical entities
- Developing strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions
- Emerging leaders in the field of quantitative drug development
- Developing understanding of the strategic elements of drug development
- Effective communication skills
- Subject matter expert
- Oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration
- Developing a developing understanding of the strategic elements of drug development
- Effective communication skills
- Increasing responsibility and independence in a similar role in pharmaceutical drug development
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