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Santa Clara, California, United States
Onsite
Job Description Summary
LI#-Hybrid
Job Description
Key responsibilities:
Brings strong AI and digital fluency, using enterprise tools to further strategic, scientific and operational leadership in clinical pharmacology
Identifies, develops and implements 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 contributes 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
Drives close interdisciplinary collaboration among the PK Science disciplines, Drug Disposition (ADME, BA), Modeling & Simulation (M&S), through PK science sub-teams.
Works in close collaboration with clinicians and clinical development colleagues to integrate PKS insights into study design, data interpretation, and project decision‑making
Models 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.
This role reports to a Therapeutic Area head within PK Sciences within Translational Medicine (TM) in Biomedical Research. PKS is a global organization situated within Translational Medicine (TM), the clinical research arm of Biomedical Research within Novartis. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, bridging drug discovery and clinical application. PK Science is an enterprise-wide organization, working across both Biomedical Research and the Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology.
Essential Requirements
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 in clinical development, or in AI strategy, to be considered for Principal Scientist II. 4+ years of experience to be considered for Senior Principal Scientist.
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
This is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered
The salary for this position is expected to range between:
Principal Scientist II: $119,700 and $222,300 per year.
Senior Principal Scientist: $138,600 and $257,400 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$119,700.00 - $222,300.00
Skills Desired
Chemistry, Clinical Pharmacology, Clinical Research, Drug Discovery Process, Initiative (Inactive), Medical Research, Patient Care, Physiology, Quality Control (QC), R&D (Research And Development) (Inactive), Simulation Software, Translational Medicine