Sr. Manager/Associate Director level role in MA. Please send resume or questions to [email protected]<mailto:[email protected]>
The Senior Manager/Associate Director of Clinical Pharmacology will be responsible for all aspects of the clinical pharmacology strategy including early (Phase 1) and late stage development (Phase 2/3 and NDA filings). This individual will provide strategic leadership and execution of clinical development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics, and drug metabolism of the drug candidate in selected preclinical and all clinical areas. She/he will also provide rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered. Key Responsibilities * Plan, prepare and review drug development plans and regulatory filings * Determine scope, design, and planning and analysis of phase 1-4 pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations required from a drug development and regulatory perspective to take a project from concept to commercialization. Responsibilities include describing results of these studies in regulatory documents (IND's NDA's, IB's, etc.) * Responsible for protocol design, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans * respond to regulatory inquires related to DMPK, PK/PD, and clinical pharmacology * Ensure appropriate PK/PD analysis including population PK, PK/PD modeling and simulation, meta-analysis, mechanistic modelling, disease state modelling as required to aid in data interpretation, trial design and/or program decision-making * Participate in writing publications and making scientific presentations consistent with development strategies and publication plan * Collaborate with preclinical development colleagues on the scientific/technical aspects of assigned studies from conception through final report, including protocol development, budget, timelines, sample handling/processing, bioanalysis (through CRO), and PK data analysis/interpretation * Maintain knowledge of relevant scientific and regulatory practices, guidance and trends, and ensure that clinical pharmacology aspects of development programs are contemporary Qualifications * PhD, PharmD or equivalent training in pharmaceutical sciences, pharmacokinetics, mathematics, or a related scientific discipline is required * For Sr. Manager, minimum of 3 years of experience in clinical pharmacology, clinical PK/PD or pharmacometrics in the biopharmaceutical industry is required for the Senior Manager level. A minimum of 6 - 8 years of relevant experience is required for the Associate Director level * Extensive understanding and hands-on experience with Modeling and Simulation (M&S) techniques in drug development (ie. PK/PD, PB/PK, systems modelling, mechanistic modeling, population PK) * Experience preparing regulatory documents, such as IND's and NDA's, as well as prior direct involvement with major regulatory filings * Expertise in providing relevant vendor and consultant oversight * Thorough knowledge and understanding of Good Clinical Practices (GCP), the clinical research drug development process, clinical investigational trials, and corresponding roles and activities * Excellent written and verbal communication skills. Ability to create high quality written reports and summary documents for use in regulatory submissions * Ability to work independently and in multi-disciplinary teams [cid:[email protected]] Brenda Roseberry Division Manager-Scientific Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 720-328-9526 - Office 315-415-4353 - Mobile 720-475-1176 - Fax [cid:[email protected]] <http://www.linkedin.com/profile/view?id=19937880&authType=name&authToken=b5d_>
