Principal Scientist I or II, PK Sciences Therapeutic Areas (Multiple Listings)
Novartis
August 17, 2026
On-site
Cambridge, MA
Clinical Research and Development
Key responsibilities:
- Represent PK Sciences in project teams, with internal stakeholders and regulators as appropriate.
- Provide expert pharmacokinetic/drug metabolism and clinical pharmacology input across Research Development to Commercial continuum.
- Define PK/PD relationships; develop dosing strategies and predictions.
- Develop and execute clinical pharmacology strategies; contribute to nonclinical/clinical study design; analyze PK and PK/PD data from discovery through late development.
- Draft PK, dosage, and PK/PD sections of protocols/reports/summaries; author pharmacokinetic/clinical pharmacology/biopharmaceutics sections for IND/IMPD and NDA/BLA; respond to Health Authority questions.
- Drive interdisciplinary collaboration across PK Sciences, Drug Disposition (ADME/BA), Modeling & Simulation (M&S) via PK sub-teams.
- Partner with clinicians and clinical development teams to integrate PKS into study design, data interpretation, and decisions.
- Use AI/ML for model-guided design, automation of preclinical/clinical data, and predictive models/regulatory document authoring.
Essential requirements:
- Ph.D./Pharm.D. with relevant experience in clinical pharmacology, drug metabolism, and pharmacokinetics.
- 0–2 years drug discovery/development experience in academia, CRO, biotech, or Pharma.
- 2+ years leading ADME/DMPK project strategy (discovery or clinical development) for Principal Scientist II.
- Deep PK knowledge (drug metabolism, PK/PD); experience working in (preferably global) project teams; awareness of regulatory science.
- Cross-functional/matrix environment experience; strong oral and written communication.
Desirable:
- Hands-on AI/ML project experience.
- Represent PK Sciences in project teams, with internal stakeholders and regulators as appropriate.
- Provide expert pharmacokinetic/drug metabolism and clinical pharmacology input across Research Development to Commercial continuum.
- Define PK/PD relationships; develop dosing strategies and predictions.
- Develop and execute clinical pharmacology strategies; contribute to nonclinical/clinical study design; analyze PK and PK/PD data from discovery through late development.
- Draft PK, dosage, and PK/PD sections of protocols/reports/summaries; author pharmacokinetic/clinical pharmacology/biopharmaceutics sections for IND/IMPD and NDA/BLA; respond to Health Authority questions.
- Drive interdisciplinary collaboration across PK Sciences, Drug Disposition (ADME/BA), Modeling & Simulation (M&S) via PK sub-teams.
- Partner with clinicians and clinical development teams to integrate PKS into study design, data interpretation, and decisions.
- Use AI/ML for model-guided design, automation of preclinical/clinical data, and predictive models/regulatory document authoring.
Essential requirements:
- Ph.D./Pharm.D. with relevant experience in clinical pharmacology, drug metabolism, and pharmacokinetics.
- 0–2 years drug discovery/development experience in academia, CRO, biotech, or Pharma.
- 2+ years leading ADME/DMPK project strategy (discovery or clinical development) for Principal Scientist II.
- Deep PK knowledge (drug metabolism, PK/PD); experience working in (preferably global) project teams; awareness of regulatory science.
- Cross-functional/matrix environment experience; strong oral and written communication.
Desirable:
- Hands-on AI/ML project experience.