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Astellas Pharma Director Pharmacometrics US, Clinical Pharmacology & Exploratory Development (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.

Purpose & Scope:

  • Provide scientific, technical, and strategic pharmacokinetic-pharmacodynamic modeling and simulation (M&S) support within and across therapeutic areas

  • Creation, review, and approval of scientific reports to document modeling activities and support registration

  • Writing of regulatory documents and interaction with regulatory agencies

  • May have mentoring/coaching or supervising responsibilities

Essential Job Responsibilities:

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

  • Peer review of M&S 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 provide M&S input to the clinical development strategy

  • Act as the M&S representative on Core Teams, Extended Teams, Early Modeling Teams, and Quantitative Quartet

  • Be actively involved in strategic modeling discussions with other pharmacometricians, and PBPK and QSP modelers

  • Represent M&S for in-house discovered or in-licensed compounds, which may include Due Diligence activities

  • Preparation of various sections of regulatory documents, such as IB, IND, and CTD, 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 M&S in general to ensure availability of state-of-the art knowledge and experience in pharmacometrics for practical application in clinical development

  • Mentoring of junior M&S scientists

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

  • Contribute to the definition, implementation and maintenance of new multidisciplinary ways of working in order to improve the efficiency and effectiveness of the Pharmacometrics group and CPED

  • Display leadership attributes that lead to the improvement of Pharmacometrics and CPED processes and level of science

  • Contribution to and review of scientific, strategic, and technical documents produced by the Pharmacometrics Group

Quantitative Dimensions:

  • Responsible for the design, analysis, and reporting of all M&S analyses associated with 3 to 10 projects per year with 1 to 4 projects at any given time

  • Responsible for management of timelines of M&S analyses related to particular studies

  • Responsible for management of costs and timelines of outsourced M&S analyses

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

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

  • May create and/or review 10 to 25 modeling reports per year for scientific and technical quality

  • The position has no direct budget responsibility

Organizational Context:

  • This position reports to the Pharmacometrics US Group Lead

  • May have functional management of scientists

  • Direct interaction with the Quantitative Quartet (clinical, statistics, clinical pharmacology science), extended CPED team members, and core team partners

Qualifications:

Required:

  • Advanced degree MD/ PhD /PharmD/MS required

  • Requires at least 8 years post-graduate PhD/MD experience or 12 years post-MS in the pharmaceutical industry with a solid understanding of drug discovery and development

  • Can integrate knowledge across all CPED functions

  • Theoretical and working understanding of modeling and simulation of pharmacokinetic- pharmacodynamic data

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

  • Basic understanding of disease biology and exposure-response M&S required to design early development strategies up to and including PoC

  • Expert working and theoretical knowledge of population pharmacokinetic-pharmacodynamic modeling methodologies and software

  • Working knowledge of Microsoft Office

  • Working knowledge with graphics software or tools

  • Expert working knowledge of a programming language such as SAS or R

  • Thorough understanding of regulatory strategies and guidelines

  • Experience in regulatory filings and interactions with regulatory authorities worldwide preferred

  • If this is a line management role, personnel management experienced highly desired

  • Demonstration of strategic thinking related to pharmacokinetic-pharmacodynamic exposure- response analyses and pooled analyses across a project

  • Good written and communication skills

  • Strong, critical analytical mind

  • Ability to operate with minimal supervision

  • Strong leadership skills

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 & Exploratory Development (CPED)

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

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