Job Description

Senior Principal Pharmacometrics

We are 60 quantitative scientists supporting more than 80 clinical development projects in 10 therapeutic areas every day. As a Senior Principal Pharmacometrics, you will be responsible for the discussion and implementation of pharmacometrics methodologies as well as providing pharmacometrics support for regulatory submissions and integrated evidence generation contributing to drug development decisions with internal and external partners.

Your Key Responsibilities

• Provide global strategic pharmacometrics leadership and support to clinical development programs of low to mid complexity, based on relevant technical and disease area knowledge
• Contextualizing the modeling question with the relevance to drug and disease biology
• Developing an understanding of drug development applied to scoping relevant questions for Pharmacometrics analysis
• Communication of modeling to project teams in multiple settings such as decision board meetings, small sub-teams, etc.
• Drive the pharmacometrics contributions to regulatory/submission strategy and related documents (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, responses to Health Authority questions) with oversights
• Assess pharmacometrics requirements insuring the integration of pharmacometrics information into transition of drug development milestones / decision boards
• Contribute to Integrated Evidence generation by leveraging disease progression and Pharmacokinetic-Pharmacodynamic modeling techniques using varied data sources, including Real World Data
• Align with the Analytics team (biometrician, data management, database programming, programming, medical and scientific writing) on the pharmacometrics strategy, execution, and delivery of assigned projects

The ideal location for this role is the Cambridge, MA or East Hanover, NJ site. This role offers hybrid working, requiring 3 days per week or 12 days per month in the office.

Role Requirements: Essential Requirements

• Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent) with 3+ years' experience in clinical drug development applying model-based methods using NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation in academia and/or industry
• Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas
• Diverse experience in pharma industry on incorporation of model-informed drug development (MIDD) strategies into drug development plans across all phases and answering challenging questions on dose and regimen justification, study design, safety analysis among others
• Ability to develop and deliver clear, concise presentations, drive discussions and decision making for both internal and external meetings

Novartis Compensation and Benefit Summary

The salary for this position is expected to range between $119,700 and $222,300 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.

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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.

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.

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