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Astellas Pharma Senior Manager Pharmacometrics PKMS, Machine Learning 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 and technical modeling and simulation support in Clinical Pharmacology to individual projects using Machine Learning approaches.

Essential Job Responsibilities:

  • Provide machine-learning based modeling and simulation support to the design and analysis of clinical and preclinical studies using Jupityr notebooks, Python, or R software

  • Develop new and innovative machine learning based methods for the analysis of clinical pharmacology data

  • Provide scientific and technical input into the design and reporting of clinical pharmacology studies

  • Responsible for providing input into recommendations and/or decisions important in successful drug development plans including innovative study designs; innovative data evaluation techniques; extrapolation of animal safety, pharmacodynamic and ADME data for dose selection in humans; innovative methods for assessment of exposure response relationship for PK parameters and efficacy and safety measures including bio-markers

  • Can successfully interface and collaborate with scientific disciplines in non-clinical and clinical across Astellas

  • Be the PKMS representative (with supervision) for in-house discovered or in-licensed compounds

  • Be actively involved in PKMS discussions

  • Maintain a current awareness of trends and developments in various expert fields of the department

  • Responsible for having scientific input into the various sections of regulatory documents, such as CTD.

  • Represent Astellas at scientific meetings

  • Manage and oversee outsourced PKMS projects, if necessary

Quantitative Dimensions:

  • Be involved in the design, analysis, and reporting at least 3 to 10 clinical studies per year

  • Lead and implement on-average 3-5 meta-analyses across studies per year

  • Responsible for management of timelines of PKMS analyses performed in-house related to particular studies

  • Responsible for management of costs and timelines of outsourced PKMS analyses related to particular studies

  • The position has no direct budget responsibility

Organizational Context:

This position reports to the Executive Director, New Technologies, Clinical Pharmacology and Exploratory Development. This position has no direct reports.

Qualifications:

Required

  • Preferred MD/ PhD /PharmD or MS with relevant experience

  • Working and theoretical knowledge of machine learning techniques such as supervised and unsupervised learning

  • Experience with deep learning highly desired

  • Strong communication skills

  • Experience in pharmaceutical industry preferred

  • Working knowledge of clinical pharmacology discipline and its methods and approaches preferred

  • Evidence of working knowledge of Python or R

  • Strong, critical analytical mind

  • Able to operate remotely with minimal supervision.

  • Key organizer and planner who clearly sets priorities.

  • Highly developed sense for ethical conduct of Clinical Development

Preferred:

  • Experience working with Jupyter Notebook

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

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Category Clinical Pharmacology and Exploratory Development (CPED)

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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