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Senior Director Pbpk Consultancy

10+ years
Not Disclosed
10 Nov. 30, 2024
Job Description
Job Type: Full Time Education: PhD/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Role: Senior PBPK Modelling Scientist

Certara is looking for an experienced and highly motivated PBPK Modelling Scientist to join their Simcyp® PBPK Consultancy Team. This team is dedicated to using PBPK modelling and simulation to influence decision-making throughout drug development, from discovery to regulatory filing. The successful candidate will take a leadership role in consultancy projects and have opportunities to contribute to both academic and commercial environments, attending scientific meetings and working closely with clients across the pharmaceutical industry.


Responsibilities

As a Senior PBPK Modelling Scientist, you will:

  • Lead consultancy projects with pharmaceutical clients to develop and apply PBPK models for various drug development applications.
  • Apply PBPK models to support multiple applications, including:
    • Drug-drug interaction (DDI) liability prediction.
    • Food effect prediction.
    • Pharmacokinetic (PK) prediction in special populations.
    • Biopharmaceutics/bioequivalence prediction.
    • Large molecule PK prediction.
  • Supervise and mentor a team of 4-5 scientists/consultants within the PBPK group, ensuring high-quality work and reviewing modelling work and regulatory responses.
  • Regularly engage with clients, both potential and existing, to foster relationships and expand the business.
  • Stay up-to-date with the latest scientific developments in PBPK and IVIVE to effectively communicate with peers, clients, and the wider scientific community.
  • Publish work and represent Certara at scientific meetings, contributing to ongoing debates and discussions in the field.

Qualifications

Education

  • A PhD in a relevant field (e.g., IVIVE, drug metabolism, pharmacokinetics).

Experience & Skills

  • 10+ years of experience in IVIVE, drug metabolism, or pharmacokinetics.
  • Extensive knowledge of PBPK modelling and its application in drug discovery and development, including an understanding of regulatory acceptance of PBPK models.
  • Strong knowledge of drug metabolism and pharmacokinetics.
  • A deep understanding of Simcyp® simulator and its capabilities.
  • Ability to lead and supervise a team of scientists/consultants (4-5 people).
  • Excellent communication skills for engaging with clients, peers, and regulatory agencies.
  • Ability to grow and expand the PBPK consultancy group globally by building a strong client base.

Why Certara?

  • Leadership Opportunities: Lead and mentor a team of talented scientists while influencing key drug development decisions.
  • Scientific Influence: High-profile role in the scientific community, including publishing, presenting, and engaging in discussions at global scientific meetings.
  • Career Development: Certara offers an exciting mix of academic and commercial environments, supporting continuous learning and development.

Certara is committed to providing equal employment opportunities, making all decisions based on merit, qualifications, and performance, while respecting diversity and inclusivity.

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