Associate Director, Pharmacometrics
Job Description The Pharmacometrics community at Novartis comprises a group of about 80 quantitative scientists supporting a portfolio of more than 80 clinical development projects in 10 therapeutic areas every day. Quantitative sciences are a critical part of bringing these new medicines to patients. Pharmacometric Scientists bring innovative modeling and simulation skills to every aspect of clinical drug development over a wide range of disease areas and drug modalities. We are dedicated to creating a collaborative and supportive culture where teamwork and learning is emphasized and innovative problem solving is encouraged. Come and join an industry leader where you will have the opportunity to grow and contribute as a quantitative drug development scientist in early- and late-stage projects.
The Associate Director, Pharmacometrics drives the pharmacometric strategy for (early/full) clinical programs in multiple indications or a disease area. In this role, you will perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches. You may manage a portfolio of projects at the disease area or indication level. You will set the strategy for addressing pharmacometric issues in regulatory submissions and directly influences drug development decisions with internal and external partners.
What you'll be doing: Your responsibilities include, but are not limited to:
* Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies.
* Lead and optimize the provision of pharmacometric contributions to regulatory/submission strategy and related documents: (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, and responses to Health Authority questions).
* Represent the Global Project Teams internally and externally, including interactions with Health Authorities and external key opinion leaders, as the recognized Novartis pharmacometrics expert within the Development Unit (or equivalent). Represent PMX at global regulatory hearings/advisory committee meetings and other global regulatory interactions.
* Represent PMX in due-diligence teams to evaluate in-licensing opportunities.
This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely. This position will require 0% travel as defined by the business (domestic and/ or international). EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Minimum requirements What you'll bring to the role:
* PhD or PharmD in Pharmaceutical sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent) with 6+ years' experience in 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 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
Why Novartis
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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.
The pay range for this position at commencement of employment is expected to be between $158,400-237,600 a year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Division Global Drug Development Work Location East Hanover, NJ Company/Legal Entity Novartis Pharmaceuticals Functional Area Research & Development
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Novartis Group Companies
parental leave, paid time off, sick time, 401(k)
June 04, 2023