Director Pharmacometrics role available, remote in the United States

Director role available, Director, Pharmacometrics, remote in the US, please email [email protected]<mailto:[email protected]> for more information Responsibilities Responsible for the design and implementation of PMX strategy at the program level; the construction, validation, and implementation of disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with colleagues * Lead design and implementation of the PMX strategy and other advanced Model Informed Drug Discovery and Development approaches to enable quantitative decision making thorough the drug development Manage and perform pharmacometric analyses, including oversight of external vendors * Department representation with project teams * Proactively contribute into key pre-clinical, clinical, and regulatory documents such as clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND and BLA/NDA's, adhering to regulatory guidelines * Maintain and enhance technical and drug development expertise (e.g. training courses, external meeting attendance) * Act as technical subject matter expert Qualifications * PhD in clinical Pharmacology/Pharmaceutical sciences/pharmacology/Statistics/engineering with training in Pharmacometrics * Minimum 10 years of hands on industry experience in Pharmacometrics, considerations will be made for a combination of academic and industry experience, and level can be flexible between AD and Director for solid candidates with less experience * Strong quantitative skills and expertise (such as mechanistic PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations) * Communication and presentation skills [image001.png] Brenda Roseberry Vice President, Scientific Recruiting Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 315-415-4353 - Mobile

Director role available, Director, Pharmacometrics, remote in the US, please email [email protected]<mailto:[email protected]> for more information Responsibilities Responsible for the design and implementation of PMX strategy at the program level; the construction, validation, and implementation of disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with colleagues * Lead design and implementation of the PMX strategy and other advanced Model Informed Drug Discovery and Development approaches to enable quantitative decision making thorough the drug development Manage and perform pharmacometric analyses, including oversight of external vendors * Department representation with project teams * Proactively contribute into key pre-clinical, clinical, and regulatory documents such as clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND and BLA/NDA's, adhering to regulatory guidelines * Maintain and enhance technical and drug development expertise (e.g. training courses, external meeting attendance) * Act as technical subject matter expert Qualifications * PhD in clinical Pharmacology/Pharmaceutical sciences/pharmacology/Statistics/engineering with training in Pharmacometrics * Minimum 10 years of hands on industry experience in Pharmacometrics, considerations will be made for a combination of academic and industry experience, and level can be flexible between AD and Director for solid candidates with less experience * Strong quantitative skills and expertise (such as mechanistic PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations) * Communication and presentation skills [image001.png] Brenda Roseberry Vice President, Scientific Recruiting Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 315-415-4353 - Mobile