A new role with a pharmaceutical client is available. Location is open to remote, NJ, MA, or MD. Please let me know if interested and email: [email protected]<mailto:[email protected]> Oversees all clinical pharmacology and pharmacometrics activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Leads study design, execution and reporting of clinical pharmacology and studies and pharmacometrics analyses and reports. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. Closely interacts with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Author/reviewer of clinical pharmacology submission documents and representative of the department at different product development team meetings. Lead pharmacometrics and simulation and modeling team members and provide input on modeling and simulation activities. Interacts with early development and business development team members as well as external collaborators to assess/lead development and selection of pre-IND and early phase assets.
Job Description * Lead clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data. * Conduct PK and PK/PD analysis. * Conduct pharmacometrics analyses or work closely with pharmacometrics team members and lead activities related to analysis and reporting of PK and PK/PD. * Lead development of clinical pharmacology sections for regulatory filings including annual reports, investigator's brochure, IND/NDA applications and pediatrics development plans. * Work with bioanalytical team members on activities related to assay development, sample management, pharmacogenomics and biomarker development. * Work with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations. * Manage clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices. * Training and mentoring of staff. * Serve as clinical pharmacology and pharmacometrics leader on multiple project teams Qualifications Knowledge, Skills, and Competencies * In-depth knowledge of clinical pharmacology, pharmacokinetics, pharmacodynamics, drug metabolism, biopharmaceutics, and bioanalytical chemistry. Hands on pharmacometrics, PK/PD and statistical analysis using NonMEM, Phoenix NLME etc. * Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis. * Great working knowledge of formulation development, drug development and clinical development. * Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents. [cid:[email protected]] Brenda Roseberry Division Manager-Scientific Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 720-328-9526 - Office 315-415-4353 - Mobile (preferred) 720-475-1176 - Fax [cid:[email protected]] <https://www.linkedin.com/in/brenda-roseberry-1608166/?msgConversationId=6641167769234657280&msgOverlay=true>
