Hybrid Principal Scientist I/II, PK Sciences

Posted 13 hours ago

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About the role

  • PK Sciences project team representative developing pharmacology strategies for transformative new medicines. Collaborates in clinical development, providing insights on drug candidates and dosing strategies.

Responsibilities

  • Represent the PK Sciences function in project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate
  • Proactively contributes to developing drug candidates across Research Development and Commercial continuum, providing expert pharmacokinetic / drug metabolism and clinical pharmacology input
  • Work with teams to elucidate the understanding of PK/PD relationships and develop dosing strategies and predictions
  • Develop and execute clinical pharmacology strategies, including input into nonclinical and clinical study design, and analyzing PK and PK/PD data, to support compound development from discovery through late development
  • Provide PK, dosage, and PK/PD components of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to Health Authority questions
  • Drive close interdisciplinary collaboration among the PK Science disciplines, Drug Disposition (ADME, BA), Modeling & Simulation (M&S), through PK science sub-teams.
  • Works in close collaboration with clinicians and clinical development colleagues to integrate PKS insights into study design, data interpretation, and project decision‑making
  • Use of Artificial intelligence (AI) / Machine Learning (ML) approaches to enable model guided molecular design, preclinical and clinical data automation, authoring regulatory documents, and the use of predictive models

Requirements

  • Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background.
  • A minimum of 0-2 years of experience in drug discovery and/or development in a relevant environment (academia, CRO, biotech or Pharma).
  • 2+ years of experience preferably in a lead role overseeing ADME/DMPK project strategy, either in discovery or clinical development to be considered for Principal Scientist II.
  • Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation.
  • Experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences.
  • Exposure to working in a cross-functional, matrixed, project-team environment.
  • Strong oral and written communication skills.

Benefits

  • health, life and disability benefits
  • 401(k) with company contribution and match
  • generous time off package including vacation, personal days, holidays and other leaves

Job title

Principal Scientist I/II, PK Sciences

Job type

Experience level

Lead

Salary

$108,500 - $201,500 per year

Degree requirement

Postgraduate Degree

Location requirements

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