Senior Director PBPK Consultancy

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.

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 continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

At Certara, we accelerate medicines to patients by partnering with life science innovators.

Our integrated and proprietary end to end platform with biosimulation, regulatory science and market access solutions combined with our strong team of scientists and subjectmatter experts enable our clients to unlock millions of dollars in R&D savings and accelerate their drug development programs.

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 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 &ndash 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&rsquore 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.

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