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Astellas Pharma Associate Director, New Technologies, CPED in Northbrook, Illinois

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

  • Provide scientific, technical, and strategic quantitative systems pharmacology (QSP) modeling and simulation support within and across TAs

  • Writing of regulatory documents and interaction with regulatory agencies

  • May act as a Clinical Pharmacology core team member and leading Clinical Pharmacology Extended Teams

Essential Job Responsibilities:

  • Perform quantitative systems pharmacology (QSP) modeling and simulation using a variety of software, which may include SimBiology and R

  • May perform pharmacokinetic-pharmacodynamic modeling and simulation using a variety of software, which may include NONMEM, MONOLIX, R, and SAS

  • Peer review of technical reports and analyses

  • Make summaries and presentations of analyses to others

  • Manage and oversee outsourced projects

  • Contribute to the design, analysis, and reporting of clinical studies for a compound and to provide QSP input to the clinical development strategy

  • Act as the QSP representative on Core Teams, Extended Teams, Early Modeling Teams, and the Quantitative Quartet

  • Be actively involved in QSP discussions and be actively involved with the PK group

  • Represent QSP for in-house discovered or in-licensed compounds, which may include due diligence activities

  • Preparation of various sections of regulatory documents, such as IB and IND, and interaction with regulatory agencies

  • May lead various working groups or initiatives to improve internal processes or best practices

  • Maintain knowledge of a particular disease area and QSP in general to ensure availability of state-of-the art knowledge and experience in pharmacokinetics for practical application in clinical development

  • Mentoring of junior scientists

  • May act as a Clinical Pharmacology core team member and leading Clinical Pharmacology Extended Teams

Quantitative Dimensions:

  • Responsible for the design, analysis, and reporting of all QSP analyses associated with 3 to 5 projects per year with 1 to 4 projects at any given time

  • Responsible for management of timelines of QSP analyses related to particular studies

  • Responsible for management of costs and timelines of outsourced QSP analyses

  • May coach 1 to 2 new staff members on company and project team related procedures within CPED

  • Responsibilities may directly impact on strategy and efficiency of clinical development of compounds

  • As a GCPL, provide the scientific lead for a cross-functional team of 15 to 25 people (e.g. scientists from PK, Translational science, bioanalytical) in the design and delivery of Exploratory Development strategies to Proof of Concept or Clinical Pharmacology strategies through registration

  • The position has no direct budget responsibility

Organizational Context:

  • This position reports to the New Technology Group Lead

  • This position has no direct reports

  • Direct interaction with Pharmacometrics Groups and other CP groups

Qualifications:

Required

  • Advanced degree MD/ PhD /PharmD required

  • Good written and communication skills

  • Requires at least 4 years post-graduate PhD experience or 9 years post-MS in the pharmaceutical industry with a good understanding of drug discovery and development

  • Demonstrated evidence of experience in developing QSP models

  • Theoretical and working understanding of modeling and simulation in general

  • Understanding of pharmacokinetic-pharmacodynamic principles and how they are applied to clinical pharmacology

  • Ability to integrate knowledge across all CPED functions

  • Basic understanding of disease biology to design early development strategies up to and including PoC

  • Expert working and theoretical knowledge of SimBiology and R (or equivalent)

  • Working knowledge of Microsoft Office

  • Working knowledge with graphics software like R, SigmaPlot, GraphPad, or Origin

  • Working knowledge of a programming language such as Matlab or R

  • Working understanding of regulatory strategies and guidelines

  • Experience in regulatory filings, eg., IND, IMPD, NDA, etc, and interactions with regulatory authorities worldwide desired

  • Strong, critical analytical mind

  • Ability to operate with minimum of supervision

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

#LI-SS

Category Clinical Pharmacology and Exploratory Development

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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