Position Summary The Director, CPQP position resides within Alexion's Clinical Pharmacology and Safety Sciences (CPSS) organization. As the CPQP lead, the incumbent is expected to provide subject matter expertise and program level functional leadership on issues related to clinical pharmacology, pharmacokinetics and pharmacodynamics (PK/PD), cell therapies, and genetic medicines from the pre-clinical stage up to the registration stage). The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
Principal Responsibilities Represent CPQP function at the Global Project Team and lead CPSS sub-team.Responsible for providing support for the preparation of the clinical pharmacology (PK, PD, biomarkers, Bioanalytical) sections of early and late-stage clinical protocols, Clin Pharm development plans, M&S plansContribute to the preparation of the pre-IND, IND, IB and IMPD documentsResponsible for the pharmacokinetic and PK/PD data analyses using standard industry data analysis softwareContribute to the design of early phase clinical trials (FIH to POC) and support project goalsResponsible for recommending the starting dose in FIH trials based on allometric scaling or physiologically based modeling or QSP modeling; Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC; Contribute to the design of late-stage clinical trials (POC-BLA/NDA) and support project goalsResponsible for the preparation of the PK/PD reports/sections of clinical study reportsProvide clinical pharmacology input and collaborate across all areas of drug development. Special emphasis on providing clinical pharmacology aspects of genetic medicines to research, toxicology, immunogenicity, clinical and commercial team colleagues.Primary owner of delivering pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software.Responsible for delivering clinical pharmacology components of clinical study protocols and clinical study reports.Qualifications Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacology/cell biology/immunology, or relevant discipline.At least 10 years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry.Exposure to genetic medicine and biologics drug development. Knowledge of clinical immunology and virology is a plus.Knowledge of data analysis methodologies for implementation in analyzing early clinical phase dataKnowledge of general regulatory process and experience in contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA and EMAExperience in genomic medicine and/or cell therapy clinical development. Hands on exposure to development issues related to recombinant DNA biology, bacterial production of plasmids, cell line biology, viral production, molecular analytical assays (qPCR, ddPCR, etc.), biochemistry analytical assays (ELISA, enzymatic activity, etc.), biophysics analytical assays (HPLC, DLS, CE-SDS, etc.), microscopy, tissue imaging (IHC, fluorescence microscopy), flow cytometryExcellent written and oral communication skills including good presentation skillsStrong business acumen; including knowledge of the multidisciplinary functions involved in a company's drug development process, e.g., clinical operations, research, biostatistics, clinical pharmacology, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-resultsEducation Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacology/cell biology/immunology, or relevant discipline
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