Director, PK Sciences Clinical Pharmacology Artificial Intelligence (AI) Lead
Novartis
Summary
We are seeking an enthusiastic and motivated PK Sciences representative to lead the development and use of artificial intelligence (AI) enabled strategies to transform the 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, focusing on developing AI-based solutions to enhance the automation, innovation and acceleration of PKS/clinical pharmacology deliverables across the organization.
Job description
Key Responsibilities
- Lead the development and oversee implementation of AI strategy for clinical pharmacology within PKS.
- Bring strong AI and digital fluency, using enterprise tools to further strategic, scientific and operational leadership in clinical pharmacology.
- Identify, develop and implement 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 contribute 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.
- 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.
- Model 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.
Essential Requirements
- Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background.
- A minimum of 8-10 years of experience in drug discovery and/or development in a relevant environment (academia, CRO, biotech or Pharma).
- 6+ years of experience preferably in a lead role overseeing ADME/DMPK project strategy in translational/clinical development, or in AI strategy.
- 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.
Desirable Requirements
- Hands-on project experience with Artificial intelligence (AI) approaches and examples of applying AI to clinical pharmacology topics is a plus.
Requirements
- Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background
- A minimum of 8-10 years of experience in drug discovery and/or development in a relevant environment (academia, CRO, biotech or Pharma)
- 6+ years of experience preferably in a lead role overseeing ADME/DMPK project strategy in translational/clinical development, or in AI strategy
- Extensive and in-depth knowledge of pharmacokinetics including drug metabolism and PK/PD evaluation
- Experience in working in project teams (preferably global)
- 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) approaches and examples of applying AI to clinical pharmacology topics is a plus
Benefits
- Health Benefits
- Life Insurance
- Disability Benefits
- 401(k) Matching
- Performance-Based Cash Incentive
- Annual Equity Awards
- Paid Vacation
- Personal Days
- Paid Holidays
- Other Leaves
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.