Director, PK Sciences Clinical Pharmacology Artificial Intelligence (AI) Lead

Novartis • Cambridge, MA

1d • $185,500 - $344,500 • Onsite

About The Position

Novartis is seeking a PK Sciences representative to lead the development and use of AI-enabled strategies that transform clinical pharmacology support for new medicines. The role applies AI to improve automation, innovation, and delivery of PK Sciences and clinical pharmacology work, using enterprise tools to strengthen strategic, scientific, and operational leadership. It may cover small molecules, biologics and therapeutic proteins, antibody-drug conjugates, radioligand therapies, and/or cell therapies across Novartis therapeutic areas. Experience spanning late discovery into clinical development is preferred.

The position promotes an integrated view of the ADME and clinical pharmacology properties of drug candidates through collaboration across PK Science disciplines, Drug Disposition (ADME, BA), Modeling & Simulation, and Operations. It also works with clinicians, clinical development colleagues, and broader cross-disciplinary project teams to integrate PK Sciences strategies and insights into project plans, study design, data interpretation, and decisions. The role contributes pharmacokinetic, drug metabolism, and clinical pharmacology expertise across drug discovery, development, and commercialization, including regulatory document authoring and responses to health authority questions.

The role reports to a Therapeutic Area Unit head within PK Sciences, part of Translational Medicine in Biomedical Research. PK Sciences is a global, enterprise-wide organization working across Biomedical Research and Development to advance pharmacokinetics, metabolism, and clinical pharmacology and bridge drug discovery with clinical application.

Requirements

• Ph.D. or Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics, or a related background.
• At least 8–10 years of experience in drug discovery and/or development in a relevant environment such as academia, a CRO, biotech, or Pharma.
• Preferably 6 or more years of experience in a lead role overseeing ADME/DMPK project strategy in translational or clinical development, or in AI strategy.
• Extensive, in-depth knowledge of pharmacokinetics, including drug metabolism and PK/PD evaluation.
• Experience working in project teams, preferably global teams.
• Sound awareness of recent developments in drug development and regulatory sciences.
• Experience working in a cross-functional, matrixed project-team environment.
• Strong oral and written communication skills.

Nice To Haves

• Late-discovery-to-clinical-development experience is preferred.
• Hands-on project experience with AI approaches and examples of applying AI to clinical pharmacology topics.

Responsibilities

• Lead the development and oversee implementation of the AI strategy for clinical pharmacology within PK Sciences.
• Use AI and digital tools to support strategic, scientific, and operational leadership in clinical pharmacology.
• Identify, develop, and implement high-value AI use cases that improve clinical pharmacology planning, analyses, and decision quality.
• Represent PK Sciences in project teams, organizational stakeholder interactions, and interactions with regulatory agencies as appropriate.
• Provide expert pharmacokinetic, drug metabolism, and clinical pharmacology input to drug candidates across the Research, Development, and Commercial continuum.
• Work with teams to use AI to improve understanding of nonclinical and clinical PK/PD relationships, development dosing strategies, and predictions.
• Use AI to improve the preparation of dosage and PK/PD components of study protocols, reports, project summaries, and development plans.
• Author pharmacokinetic, clinical pharmacology, and biopharmaceutics sections of INDs/IMPDs and NDAs/BLAs, and prepare appropriate responses to health authority questions.
• Drive interdisciplinary collaboration across PK Science disciplines, Drug Disposition (ADME, BA), and Modeling & Simulation through PK Science sub-teams.
• Collaborate with clinicians and clinical development colleagues to integrate PK Sciences insights into study design, data interpretation, and project decision-making.
• Model the use of AI and machine-learning approaches for model-guided molecular design, preclinical and clinical data automation, and regulatory document authoring.

Benefits

• Performance-based cash incentive.
• Eligibility to be considered for annual equity awards, depending on role level.
• Comprehensive benefits package for eligible U.S.-based employees, including health, life, and disability benefits.
• 401(k) with company contribution and match.
• Vacation, personal days, holidays, and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree