Principal Scientist II/Senior Principal Scientist, PK Sciences Clinical Pharmacology Artificial Intelligence (AI) Lead (dual level posting)

About the role

The successful candidate will offer insight into the development and use of artificial intelligence (AI) enabled strategies to transform clinical pharmacology support of transformative new medicines. They will focus on developing AI-based solutions to enhance the automation, innovation and acceleration of PKS/clinical pharmacology deliverables across the organization.

The scope of the role potentially includes small molecules, biologics/therapeutic proteins, antibody drug-conjugates, radioligand therapies and/or cell therapies across major therapeutic areas in Novartis, including oncology, immunology, cardiovascular renal metabolism, neuroscience, and global health. This position drives close interdisciplinary collaboration among the PK Science disciplines, Drug Disposition (ADME, BA), Modeling & Simulation (M&S), and Operations through PK science sub-teams to achieve a holistic and integrative perspective of the ADME/clinical pharmacology properties of candidates and drugs.

Collaborate effectively with broader, cross-disciplinary project teams to ensure PKS strategies are well integrated into project plans and scientific discussions.

Key responsibilities

• Bridges the gap between AI and clinical pharmacology, using enterprise tools to further strategic, scientific and operational leadership in clinical pharmacology.
• Identifies, develops and implements high-value use cases where AI can materially improve clinical pharmacology planning, analyses and decision quality.
• Represents 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.
• Works with teams to use AI to accelerate and enhance the understanding of nonclinical and clinical PK/PD relationships and development dosing strategies and predictions.
• Champions the use of AI to accelerate and enhance the provision of, 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.
• Drives 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.
• Models the use of Artificial intelligence (AI) / Machine Learning (ML) approaches to enable model guided molecular design, preclinical and clinical data automation, and authoring regulatory documents.

Essential 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 in clinical development, or in AI strategy, to be considered for Principal Scientist II. 4+ years of experience to be considered for Senior Principal Scientist.
• 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.

Desirable requirements

• Hands-on project experience with Artificial intelligence (AI) approaches and examples of applying AI to clinical pharmacology topics is a plus.

Pay

This role's pay range is between $119,700 and $222,300 per year for a Principal Scientist II and between $138,600 and $257,400 per year for a Senior Principal Scientist. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.