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Novartis

Global pharmaceutical company delivering science-based innovations

Director Lead - PK Sciences Clinical Pharmacology Artificial Intelligence

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeCambridge, MA, USA

About the Job

Requirements

  • A Ph.D. or Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics, or a related background.
  • At least 8–10 years of experience in drug discovery and/or development in a relevant environment such as academia, a contract research organization, biotechnology, or pharmaceutical industry.
  • Preferably 6 or more years of experience in a lead role overseeing ADME/DMPK project strategy in translational or clinical development, or in AI strategy.
  • Extensive and in-depth knowledge of pharmacokinetics, including drug metabolism and pharmacokinetic/pharmacodynamic evaluation.
  • Experience working in project teams, preferably global, and sound awareness of recent developments in drug development and regulatory sciences.
  • Exposure to a cross-functional, matrixed project-team environment.
  • Strong oral and written communication skills.

Responsibilities

  • Lead the development and oversee implementation of AI strategy for clinical pharmacology within PK Sciences.
  • Use enterprise tools and AI and digital fluency to support strategic, scientific, and operational leadership in clinical pharmacology.
  • Identify, develop, and implement high-value use cases where AI can materially improve clinical pharmacology planning, analyses, and decision quality.
  • Represent PK Sciences in project teams, organizational stakeholder interactions, and interactions with regulatory agencies as appropriate.
  • Contribute proactively to drug candidates across the Research, Development, and Commercial continuum by providing expert pharmacokinetic, drug metabolism, and clinical pharmacology input.
  • Work with teams to use AI to improve understanding of nonclinical and clinical pharmacokinetic/pharmacodynamic relationships and development dosing strategies and predictions.
  • Champion AI use to improve preparation of dosage and pharmacokinetic/pharmacodynamic components of study protocols, reports, project summaries, and development plans; author pharmacokinetic, clinical pharmacology, and biopharmaceutics sections of INDs, IMPDs, NDAs, and BLAs; and prepare appropriate responses to health authority questions.
  • Drive interdisciplinary collaboration among PK Science disciplines, Drug Disposition (ADME, BA), and Modeling & Simulation through PK Science sub-teams.
  • Collaborate with clinicians and clinical development colleagues to integrate PK Sciences insights into study design, data interpretation, and project decision-making.
  • Model the use of artificial intelligence and machine learning approaches for model-guided molecular design, preclinical and clinical data automation, and regulatory document authoring.

Desired Qualifications

  • Hands-on project experience with artificial intelligence approaches and examples of applying AI to clinical pharmacology topics.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

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