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

Job Description Summary

LI#-Hybrid
Location: Cambridge (USA)

We are seeking an enthusiastic and motivated PK Sciences representative to lead the development and use of artificial intelligence (AI) enabled strategies to transform clinical pharmacology support of transformative new medicines. The successful candidate will offer insight into the development of AI-based applications to support strategic, scientific and operational leadership. They would focus on developing AI-based solutions to enhance the automation, innovation and acceleration of PKS/clinical pharmacology deliverables across the organization. Our unique organizational structure enables colleagues to work seamlessly in the translational and/or clinical space, offering opportunities for development and bench-to-bedside-to-bench translation. Experience in late discovery into clinical development is preferred. 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.

 

Job Description

Key responsibilities:

• Brings strong AI and digital fluency, 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.

• 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 use AI to accelerate and enhance the understanding of nonclinical and clinical PK/PD relationships and development dosing strategies and predictions

• Champion 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.

This role reports to a Therapeutic Area head within PK Sciences within Translational Medicine (TM) in Biomedical Research. PKS is a global organization situated within Translational Medicine (TM), the clinical research arm of Biomedical Research within Novartis. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, bridging drug discovery and clinical application. PK Science is an enterprise-wide organization, working across both Biomedical Research and the Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology.

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 kno