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Lead Quantitative Pharmacologist
2 months ago
We are seeking a Lead Quantitative Pharmacologist to play a pivotal role in advancing various programs. This position entails the execution of pharmacokinetic (PK), pharmacodynamic (PD), and other quantitative analyses that are crucial for the progression of these initiatives. The individual in this role will collaborate across departments to evaluate, design, select, and implement standardized scientific methodologies for analyzing both in-vivo and in-vitro pharmacokinetic and pharmacodynamic studies.
A typical day for a Lead Quantitative Pharmacologist may include:
- Collaborating with team members under moderate supervision to plan, design, implement, and analyze results for a variety of pharmacometric (PMx) studies.
- Conducting a wide range of quantitative PK or PK/PD analyses, including but not limited to non-compartmental analysis (NCA), compartmental modeling, population pharmacokinetics (PopPK), translational modeling, disease modeling, population PK/PD, and exposure-response analyses, often in close collaboration with Research Specialists or the PMx Statistics Programming team to deliver PMx results.
- Working alongside PMx Research Specialists, PMx Programming Team, Scientific Writers, and other contributors to prepare tables, figures, and listings (TFLs) in support of various internal or regulatory documents such as PK/PD study reports, Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), and summary modules for Clinical Study Reports (CSR) and Investigator's Brochures (IB).
- With guidance from senior PMx staff, assisting in the preparation of materials for regulatory interactions, including PMx materials for regulatory background packages for pre-IND, End-of-Phase 2 (EOP2), and pre-BLA meetings, and performing additional analyses as necessary to support these interactions.
This role may be a good fit for you if:
- You possess strong interpersonal and communication skills, both written and verbal, and can work independently.
- You are familiar with regulatory and research guidelines pertaining to drug development, such as ICH and GxP guidelines.
- You seek to work in an environment that values data integrity.
- You are prepared to make independent decisions for assigned studies or indications while proactively seeking management input when necessary to ensure successful outcomes.
To be considered for this position, you must:
- Hold a PhD and have a minimum of 3 years of relevant experience.
- Demonstrate an advanced understanding of quantitative concepts and techniques, including non-compartmental analysis methods, compartmental modeling, translational pharmacology, exposure-response analysis methods, nonlinear mixed-effects modeling, and disease modeling/quantitative systems pharmacology (QSP).
- Have experience with advanced pharmacometric statistical methods applicable to clinical trials, such as survival analysis, stratified or covariate analyses, strategies for handling missing data, logistic regression, survival analysis, and Bayesian approaches.