Senior Director PBPK Consultancy

7 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.

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 and leading 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.
  • Is expected to be self running in consultancy projects
  • 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.
  • You will engage with potential and existing clients on a regular basis.
  • You will oversee work performed by others in your team, including reviewing modelling work, regulatory responses and developing modelling and simulation plans.
  • You will grow and mentor the PBPK consultancy group.
  • You will have a high profile in the scientific community - you will continue to publish your work, give talks at scientific meetings and engage in scientific debate with clients.


Qualifications

  • A PhD degree in a relevant field or equivalent experience in the field of IVIVE/ drug metabolism/ pharmacokinetics.
  • 10 years of experience in the field of IVIVE/drug metabolism/Pharmacokinetics.
  • In depth knowledge of the application of PBPK modelling in the drug discovery and development process and be aware of its acceptance across the various regulatory bodies.
  • Has in depth knowledge and understanding of IVIVE/ drug metabolism/ pharmacokinetics.
  • Should have a good overview of the simulator with good knowledge and understanding of specific areas.
  • Ability to supervise 4-5 scientists and/or consultants within the PBPK group.
  • Excellent communication skills to effectively engage with peers and clients within industry, academia and regulatory agencies.
  • We're looking for somebody who has the respect of their peers in the industry such that it allows them to grow their own clients base and expand the PBPK consultancy group globally.

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 Director PBPK Consultancy

    2 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...

  • 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...

  • Senior Director PBPK Consultancy

    1 week 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

    21 hours 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 PBPK Consultant

    1 week 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

    1 week 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...

  • Principal PBPK Consultant

    1 week 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...

  • Principal PBPK Consultant

    1 week 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...

  • Director/Senior Director, DMPK and Clinical Pharmacology

    2 days ago

    South San Francisco, CA, United States IDEAYA Biosciences Full time

    What you’ll do: Provide expert guidance on all aspects of clinical pharmacology programs supporting drug discovery and clinical development, including authoring clinical protocols, study reports, data analysis (exposure/efficacy/safety) to supporting development and registration of IDEAYA products. One of the key roles of this position is to apply...

  • Senior Consultant

    3 days ago

    Westmont, IL, United States The Pomykala Group Full time

    Senior Consultant Responsibilities As a senior consultant, you will take on additional responsibilities related to work as a consultant, but with much less supervision. You will begin to: Direct new and experienced consultants Instruct them in tasks to be performed Review their work Direct necessary revisions within a compassionate teaching environment With...

  • Managing Consultant, Art Director

    3 days ago

    , WV, United States LHR Full time

    Managing Consultant, Art Director (Senior Level) ERM's Digital Services is seeking a highly talented and detail-oriented Managing Consultant, Art Director with an impressive portfolio to join our growing, global design team. This position is a hybrid work model in the proximity of our Cleveland, Philadelphia, Pittsburgh, Charlotte, Washington D.C., or...

  • Microsoft Dynamics CRM Senior Managing Consultant

    2 days ago

    Redmond, WA, United States Maania Consultancy Services Full time

    Microsoft Dynamics CRM Senior Managing Consultant Full-time Our fortune 100 client is looking for Microsoft Dynamics CRM Sr. Managing Consultant across the US. If you are interested, please send your updated resume along with your current/expected salary. Position: Microsoft Dynamics CRM Sr. Managing ConsultantLocation: Across USDuration: Full Time /...

  • Consulting Senior Associate

    2 days ago

    Houston, TX, United States Eagle Hill Consulting Full time

    Collaborate, contribute, and create impactful solutions When you bring your background and experiences to Eagle Hill, you become a multi-talented, knowledgeable consultant who creates real, lasting impact. Explore our career opportunities below. Open roles Our continuous growth and learning opportunities Eagle Hill has six career levels with specific...

  • Consultant / Senior Consultant / Prin...

    3 days ago

    , PA, United States Turner & Townsend Group Full time

    Full-time Department: Infrastructure Company Description At Turner & Townsend we are passionate about making the difference, transforming performance on the world’s most impactful programmes for a green, inclusive, and productive world. That means challenging ourselves and others to deliver better outcomes for our clients, helping each other to make the...

  • Consultant / Senior Consultant / Prin...

    3 days ago

    , PA, United States Turner & Townsend Group Full time

    Full-time Department: Infrastructure Company Description At Turner & Townsend we are passionate about making the difference, transforming performance on the world’s most impactful programmes for a green, inclusive, and productive world. That means challenging ourselves and others to deliver better outcomes for our clients, helping each other to make the...

  • Consultant / Senior Consultant / Prin...

    3 days ago

    , PA, United States Turner & Townsend Group Full time

    Full-time Department: Infrastructure Company Description At Turner & Townsend we are passionate about making the difference, transforming performance on the world’s most impactful programmes for a green, inclusive, and productive world. That means challenging ourselves and others to deliver better outcomes for our clients, helping each other to make the...

  • Managing Consultant, Art Director

    2 days ago

    Cleveland, OH, United States Environmental Resources Management (ERM) Full time

    Managing Consultant, Art Director (Senior Level) ERM’s Digital Services is seeking a highly talented and detail-oriented Managing Consultant, Art Director with an impressive portfolio to join our growing, global design team. This position is a hybrid work model in the proximity of our Cleveland, Philadelphia, Pittsburgh, Charlotte, Washington D.C., or...

  • Microsoft Dynamics CRM Senior Managing Consultant

    2 days ago

    City of Daşşak, NY, United States Maania Consultancy Services Full time

    Microsoft Dynamics CRM Senior Managing Consultant Our fortune 100 client is looking for Microsoft Dynamics CRM Sr. Managing Consultant across the US. If you are interested, please send your updated resume along with your current/expected salary. Position: Microsoft Dynamics CRM Sr. Managing Consultant Location: Across US Duration: Full Time / Permanent...

  • Director / Senior Director, Audit Advisory

    3 days ago

    , NC, United States Ankura Full time

    Ankura is a team of excellence founded on innovation and growth. Our Audit Advisory Team of professionals includes several former senior officials from the PCAOB, including the Divisions of Enforcement and Investigation (DEI) and Registrations and Inspections (DRI). In addition, we have former senior officers from the SEC Division of Enforcement, certified...

  • Director / Senior Director, Audit Advisory

    2 days ago

    , CT, United States Ankura Full time

    Ankura is a team of excellence founded on innovation and growth. Our Audit Advisory Team of professionals includes several former senior officials from the PCAOB, including the Divisions of Enforcement and Investigation (DEI) and Registrations and Inspections (DRI). In addition, we have former senior officers from the SEC Division of Enforcement, certified...