Principal Scientist I or II, PK Sciences Therapeutic ; Listings

Location

Hybrid:
Cambridge (USA)

We are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement translational or clinical pharmacology strategies to support the pursuit of transformative new medicines through late clinical development. 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.

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

• Represent the PK Sciences function in project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate
• Proactively contribute 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
• Work 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

This role reports to the Therapeutic Area group in PK Sciences within Translational Medicine (TM) in Biomedical Research.

• 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 ScientistII
• 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

• Hands‑on project experience with Artificial intelligence (AI) / Machine Learning (ML) approaches

• Delivers results through disciplined execution, continuous improvement, and a strong focus on value and outcomes
• Demonstrates an enterprise…