We are looking for a Senior Quantitative Pharmacologist to provide significant contributions in support of multiple programs. The person in this role is responsible for the execution of PK, PD, and other types of quantitative analyses that significantly contribute to the development these programs. The Senior Scientist should work collaboratively across the organization to, evaluate, design, select and apply standardized scientific techniques to analyze in-vivo and in-vitro pharmacokinetic & pharmacodynamic studies. We need this person for the preparation and timely delivery of accurate and well-articulated nonclinical or clinical study reports, and regulatory submission documents.
A typical day in the life of a Senior Quantitative Pharmacologist may look like:
In collaboration with other team members, and modest supervision; plans, designs, implements and analyzes results for a variety PMx studies.
• Performing a broad array of quantitative PK or PK/PD analyses such as but not limited to NCA, compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E-R analyses (or in close collaboration with Research Specialist or PMx Stats Programming team) to deliver PMx results. Works with supervision to develop interpretation and discussion of results.
• Works collaboratively with PMx Research Specialists, PMx Programming Team, Scientific and Writers, and/or other contributors to prepare TFLs in support of a number of internal or regulatory documents such as PK/PD study reports, IND/CTA, summary modules CSR, IB, etc. Works in conjunction with Scientific Writing, QC and QAA (as required) to complete final draft documentation in support of IND/CTA submissions and other regulatory documents.
• With mentorship from senior PMx staff, supports preparation of material to be used in regulatory interactions. Prepares PMx materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings. Performs additional analyses as required to support regulatory interactions.
This may be the right role for you if:
• You have excellent interpersonal and communication skills both written and oral and ability to function Independently
Familiarity with regulatory/ research guidelines on drug development, (eg. ICH and GxP guidelines)
• Want to work in an organization where data intimacy is valued
• You are looking to make decisions independently for assigned studies or indication while proactively seeking line management intervention where needed to ensure successful outcome.
In order to be considered qualified, you must:
Have a minimum of a PhD and 3+ years of relevant experience. Experience should include an advanced understanding of quantitative concepts and techniques, including: non-compartmental analysis methods, compartmental modeling, translational modelling/pharmacology, Exposure-Responses analysis methods, Nonlinear Mixed Effects modeling, disease modelling/QSP*.
We expect experience with advanced PMx statistical methods and the applicability to clinical trials: such as survival analysis, stratified or covariate analyses and strategies for handling missing data, logistic regression, survival analysis, Bayesian approaches*.
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