Principal Scientist I or II, PK Sciences (Therapeutic Areas)

About the role

Novartis is looking for a PK Sciences project team representative in Cambridge (USA) to develop and implement translational or clinical pharmacology strategies that support new medicines through late clinical development. The role works across small molecules, biologics, antibody drug conjugates, radioligand therapies and cell therapies, and collaborates with Drug Disposition (ADME, BA), Modeling & Simulation and Operations. It reports to the Therapeutic Area group in PK Sciences within Translational Medicine.

Key responsibilities

• Represent PK Sciences in project teams and interact with internal stakeholders and regulatory agencies where appropriate
• Contribute to drug candidate development with expert pharmacokinetic, drug metabolism and clinical pharmacology input
• Help define PK/PD relationships and develop dosing strategies and predictions
• Develop and run clinical pharmacology strategies, including input to nonclinical and clinical study design and analysis of PK and PK/PD data
• Provide PK, dosage and PK/PD parts of protocols, reports, project summaries and development plans, and write PK/clinical pharmacology sections of IND/IMPDs and NDA/BLAs, including responses to Health Authority questions
• Collaborate with clinicians and clinical development colleagues to integrate PK insights into study design, data interpretation and project decisions
• Use AI and machine learning approaches for model-guided design, data automation, regulatory document authoring and predictive modeling

Required profile

• Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background
• 0-2 years of experience in drug discovery and/or development (academia, CRO, biotech or pharma)
• For Principal Scientist II: 2+ years in a lead role overseeing ADME/DMPK project strategy in discovery or clinical development
• In-depth knowledge of pharmacokinetics, drug metabolism and PK/PD evaluation, and experience in project teams (preferably global)
• Exposure to cross-functional, matrixed project environments and strong communication skills

Required skills

• Pharmacokinetics, drug metabolism and PK/PD evaluation
• Desirable: hands-on project experience with AI and machine learning approaches

What we offer

• Principal Scientist I: $108,500-$201,500 per year; Principal Scientist II: $119,700-$222,300 per year
• Performance-based cash incentive and possible annual equity awards
• Health, life and disability benefits, 401(k) with company contribution and match, and a time-off package