Job Description Summary 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.
Job Description
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
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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.
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network 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 - $222,300.00Skills Desired
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