Senior PBPK Consultant

8 hours ago

Wayne, United States Certara USA, Inc. Full time
Overview

About Certara

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.

In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services.

Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.

The Certara Simcyp PBPK consultancy team is a global organisation focussed on using the Simcyp physiologically-based pharmacokinetic (PBPK) platform to influence decision making on drug development programs from discovery to regulatory filing. Our PBPK consultants work with 100s of clients to inform human PK prediction, drug-drug interaction assessment, special population predictions and biopharmaceutics strategy.

We are seeking highly motivated and talented PBPK modelling scientists and experts with a DMPK, PBPK and/or a biopharmaceutics modelling background who share our passion for using PBPK models to understand and impact drug discovery and development questions.

The successful candidate will join an internationally recognised, multidisciplinary company, providing opportunities for further development of knowledge and skills. We offer a unique and exciting mix of academic and commercial environments which encourage regular attendance at scientific meetings as part of our continuous education programmes.

The post does not include routine laboratory or clinical work.


Responsibilities

The role involves contributing to consultancy projects with clients in the Pharmaceutical Industry to develop PBPK models for particular projects of interest.

Apply PBPK models in support of a number of applications including but not limited to the following:

  • DDI liability prediction;
  • Food effect prediction
  • PK prediction in special populations
  • Biopharmaceutics/bioequivalence prediction
  • Large molecule PK prediction.
  • You will lead consultancy projects (model development, verification and application) or contribute to consultancy projects with minimal supervision.
  • You will need to keep abreast of the latest scientific development in the area of PBPK and IVIVE to enable effective communication with colleagues, clients and the wider scientific community.

Qualifications

  • A PhD degree in a relevant field or equivalent experience in the field of IVIVE/ drug metabolism/ pharmacokinetics.
  • 5 years of experience in the field of IVIVE/drug metabolism/Pharmacokinetics.
  • Should have knowledge of the application of PBPK modelling in the drug discovery and development process.
  • Has a sound knowledge and understanding of IVIVE/ drug metabolism/ pharmacokinetics.
  • Should have a good overview of the simulator with good knowledge and understanding of specific areas.
  • Excellent communication skills to effectively engage with peers and clients within industry, academia and regulatory agencies.

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

RequiredPreferredJob Industries
  • Other

  • Senior PBPK Consultant

    7 days ago

    Wayne, United States Certara USA, Inc. Full time

    Job DescriptionOverviewAbout CertaraCertara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.In the past 6 years, over 90% of...

  • Senior PBPK Consultant

    7 days ago

    Wayne, United States Certara USA, Inc. Full time

    OverviewAbout CertaraCertara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries. In the past 6 years, over 90% of companies that...

  • Senior Director PBPK Consultancy

    7 days ago

    Wayne, United States Certara USA, Inc. Full time

    Job DescriptionOverviewAbout CertaraCertara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.The Certara Simcyp PBPK consultancy team...

  • Senior PBPK Consultant

    3 days ago

    Wayne, PA, United States Certara USA, Inc. Full time

    Overview About Certara Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries. In the past 6 years, over 90% of companies...

  • Principal PBPK Consultant

    7 days ago

    Wayne, United States Certara USA, Inc. Full time

    Job DescriptionOverviewAbout CertaraCertara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countriesCertara accelerates medicines using...

  • Senior Director PBPK Consultancy

    1 day ago

    Wayne, PA, United States Certara USA, Inc. Full time

    OverviewAbout CertaraCertara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries. The Certara Simcyp PBPK consultancy team is a global...

  • Senior Director PBPK Consultancy

    7 days ago

    Wayne, PA, United States Certara USA, Inc. Full time

    OverviewAbout CertaraCertara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries. The Certara Simcyp PBPK consultancy team is a global...

  • Principal PBPK Consultant

    7 days ago

    Wayne, PA, United States Certara USA, Inc. Full time

    OverviewAbout CertaraCertara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countriesCertara accelerates medicines using proprietary...

  • Senior Operations Consultant

    1 week ago

    Fort Wayne, Indiana, United States Adex Corporation Full time

    We are seeking a Senior Operations Consultant to join our team at Adex Corporation. The ideal candidate will have experience in driving optimal performance and continuous improvement among suppliers by conducting regular site visits, consulting directly with suppliers, and correcting real-time discrepancies.About the RoleThis is a fantastic opportunity for...

  • Management Consultant

    2 months ago

    Fort Wayne, United States ECI Management Full time

    Job DescriptionJob DescriptionAre you ready to make a change in your career? Are you ready to catapult yourself and your skillset to the next level? Ethereal Consulting is searching for an entry-level Management Consultant who is looking to do just that! As a top leader in the Sales, Marketing, and Business Consulting industry, we take great pride in leading...

  • Senior Pharmaceutical Labeling Lead Consultant

    1 week ago

    Fort Wayne, Indiana, United States Lifelancer Full time

    About the Role:We are seeking a highly experienced Senior Pharmaceutical Labeling Lead Consultant to join our team. As a key member of our labeling operations, you will be responsible for providing strategic support and leadership to our labeling team.Key Responsibilities:Provide project management to the labeling team throughout the process from request to...

  • IT Senior Auditor

    1 week ago

    Wayne, United States Vanguard Full time

    Vanguard's Internal Audit and SOX department has an exciting opportunity for an IT Senior Internal Auditor on our Global Technology Audit Services (GTAS) Team. In this role, you will complete risk-based audit and consulting engagements to evaluate management’s internal controls and influence senior levels of management to take action to improve the control...

  • Scientist

    2 weeks ago

    Wayne, United States Certara USA, Inc. Full time

    OverviewAbout Certara Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and...

  • Scientist, QSP

    7 days ago

    Wayne, United States Certara USA, Inc. Full time

    OverviewAbout Certara Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and...

  • Scientist, QSP

    7 days ago

    Wayne, United States Certara USA, Inc. Full time

    Job DescriptionOverviewAbout CertaraCertara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for...

  • Internal Audit IT Senior Engagement Manager

    2 weeks ago

    Wayne, United States Vanguard Full time

    Vanguard has an exciting new opportunity for an IT Senior Engagement Manager in its Internal Audit Department within the Global Technology Audit Services (GTAS) team. This role is instrumental in evaluating technology-related risks and controls across Vanguard. In this role, you will lead and contribute to matrixed teams to complete risk-based audit...

  • QMA (Qualified Medication Aide)

    13 hours ago

    Fort Wayne, United States American Senior Communities Full time

    **Description** **_QMA_** **_Full-Time Opportunities! Night Shift!_** **_Bring your heart to work!_** **_Caring people make the difference at American Senior Communities!_** **_Compassion, Accountability, Relationships and Excellence_** are the core values for American Senior Communities. These words not only form an acronym for C.A.R.E., they are our...

  • QMA (Qualified Medication Aide)

    1 week ago

    Fort Wayne, United States American Senior Communities Full time

    QMAFull-Time Opportunities! Night Shift!Bring your heart to work! Caring people make the difference at American Senior Communities!Compassion, Accountability, Relationships and Excellence are the core values for American Senior Communities. These words not only form an acronym for C.A.R.E., they are our guiding principles and create the framework for all our...

  • Senior Accountant IN

    2 weeks ago

    fort wayne, United States Creative Financial Staffing Full time

    Seeking Consulting Senior Accountant - Lucrative Insurance Organization!The Senior Accountant will play a key role in maintaining the company's financial integrity by performing accounting activities, financial analysis, and reporting in accordance with generally accepted accounting principles (GAAP) and regulatory requirements. The Senior Accountant will...

  • Senior Accountant IN

    2 weeks ago

    fort wayne, United States Creative Financial Staffing Full time

    Seeking Consulting Senior Accountant - Lucrative Insurance Organization!The Senior Accountant will play a key role in maintaining the company's financial integrity by performing accounting activities, financial analysis, and reporting in accordance with generally accepted accounting principles (GAAP) and regulatory requirements. The Senior Accountant will...