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Senior Pharmacometrician/Associate Director Pharmacometrics

Company: CSL Behring
Location: King Of Prussia
Posted on: February 16, 2020

Job Description:

About CSLWith operations in 35+ nations and - 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Job DescriptionThe Clinical Pharmacology and Pharmacometrics team of CSL Behring is seeking a Senior Pharmacometrician/AD Pharmacometrics responsible for activities within specific projects at the pre-clinical stage as well as those across all clinical stages at CSL. This role will contribute to the pharmacometric strategy for projects, regulatory submissions, or interactions with authorities, working in parallel to Clinical Pharmacologists, Clinical Program Directors, and other experienced Clinical Development Team (CDT) colleagues, at a project level to align and set pharmacometrics strategy. This role will also assist in interactions with external consultants or with academic institutions. There is a degree of flexibility with regards to level (see qualifications/experience section below)--depending upon experience, this role can be filled at the Pharmacometrician, Senior Pharmacometrician or Associate Director level. At the Associate Director level, the individual assuming this role will have a strong and proven pharmacokinetic/pharmacometrics knowledge, with demonstrable modelling and simulation skills, and will work in close collaboration with various non-clinical, Research, Clinical R&D, & Commercial Development/Medical Affairs functions. The role will work significantly independently, requiring minimal technical management or guidance. A considerable amount of initiative and strategic thinking will also be expected. This role may also be able to supervise more junior-level Pharmacometricians who will be serving at a project and/or a study level and will also assist in interactions with senior-level external consultants or with academic institutions. Responsibilities

  • Lead the implementation of model-based drug development strategies for assigned preclinical, clinical, and lifecycle management projects
  • Manage all necessary hardware and software systems, together with relevant quality processes, for the conduct of in-house pharmacometrics activities.
  • Execute relevant pharmacometric analyses for assigned preclinical, clinical, and lifecycle management projects: non-compartmental PK, PK/PD analyses, population PK and PK/PD, clinical trial simulations, meta-analyses, disease and systems biology modelling, and other modeling and simulation activities as appropriate for the project.
  • Apply innovative analytical methods in pharmacometrics/modelling and simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states in support of optimal study designs
  • Provide pharmacometrics contributions to regulatory documents including Investigator Brochures, Labelling and those required for regulatory meetings and regulatory filings. Provides resolution of pharmacometrics queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queries
  • Write Modeling & Simulation Analysis Plans and Reports. Provides input for, or leads derivation of, standard operation procedures and best practices in pharmacometrics for the Early Development function
  • Provide technical support to Research in the development of preclinical PK/PD model required for early clinical development strategy, as well as utilizing Pharm-Tox data appropriately to make clinical dosing decisions.
  • Analyze and interpret all study PK, PK/PD and pharmacometric outcomes. Ability to create PK/PD files according to standard specifications and to generate tables and listings as required
  • Develop external alliances with consultants, contract organizations and academic institutions to ensure timely conduct of all pharmacometrics deliverables for projects, to continually keep abreast of the science, as well as development of more junior colleagues in the discipline
  • Input to licensing projects as needed
  • Associate Directors will act as a mentor to junior pharmacometricians, providing strategic and technical guidance for their activities. Education: Doctoral degree with demonstrated expertise in pharmacometrics and strong quantitative skills (e.g. proven experience in most of the following areas: population and PK/PD modelling, mechanistic modelling, systems biology, species scaling methodologies and derivation of first-in-human doses, disease modelling and meta-analyses).Experience:
    • Associate Director: A minimum of 5 years of pharmaceutical industry (or relevant) experience ,specifically contributing to pharmacometrics aspects of clinical drug development.
    • Senior Pharmacometrician: A minimum of 3 years, specifically contributing to pharmacometrics aspects of clinical drug development.
    • Pharmacometrician: A minimum of 1 year experience of pharmaceutical industry (or relevant) experience, specifically contributing to the pharmacometrics aspects of clinical drug development.For all levels:
      • In-depth knowledge and experience in advanced PK and PK/PD
      • Advanced pharmacometric knowledge in one of the following core sub-speciality: Systems Pharmacology, advanced Exposure-Response Models, Disease Models, Physiological-Based Pharmacokinetic Models
      • Advanced knowledge and experience of software such as NONMEM, SAS, S-Plus, R, WinNonlin, and other server-based data processing and modelling tools
      • Knowledge of the role of pharmacometrics in drug development and FDA/ICH requirements for drug registration
      • Knowledge and application of statistics, random effects modelling, mixed effects modelling, data mining, population PK/PD analyses and modelling (including nonlinear models), Bayesian methods, clinical utility indices, and Monte-Carlo simulation, and clinical trial design and simulation
      • Ability to understand, lead and implement all aspects of pharmacometrics needs across a variety of disease areasCompetencies:
        • Excellent skills in the use of NONMEM, PsN, R, and Phoenix.
        • Excellent communication skills with demonstrated ability to effectively present any aspect of this highly technical field, as well as its plans/strategies, accordingly to various audiences in both verbal and written form.
        • Excellent oral presentation skills.
        • Ability to independently lead, conduct, and communicate pharmacometrics plans/strategies and analyses.
        • Ability to create publications according to international scientific standards.
        • Good interpersonal skills, including a positive and constructive attitude and ability to effectively work in a team matrix environment. Negotiation and influential skills advantageous.
        • Ability to work collaboratively within a matrixed organization.

Keywords: CSL Behring, Philadelphia , Senior Pharmacometrician/Associate Director Pharmacometrics, Executive , King Of Prussia, Pennsylvania

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