Associate Director, Pharmacometrics
Company: Novartis Group Companies
Posted on: March 18, 2023
Associate Director, Pharmacometrics
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. Pharmacometrics 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 pharmacometrics strategy for (early/full) clinical programs in multiple indications or a disease area. In this role, you will bring a broad and deep knowledge of modeling methodologies able to take on complex projects and provide strategic support on key drug development decisions. You will mentor and supervise execution of the pharmacometrics strategy in those programs when working with junior pharmacometricians. When given responsibilities to manage a project portfolio at the disease area or indication level, you will set the strategic role for pharmacometrics with a sound knowledge of the drug and disease biology and build strong collaborative relationships with key stakeholders.
What you'll be doing: Your responsibilities include, but are not limited to:
* Provide global strategic pharmacometrics leadership for (early/full) clinical development programs of medium to high complexity, based on relevant technical and disease area knowledge.
* Represent the early/late Global Project Teams internally and externally as the pharmacometrics expert, including in regulatory interactions.
* Be a strong voice for pharmacometrics and decision and governance boards on model informed drug development.
* Leads the pharmacometrics evaluation of competing program/trial/analysis strategies assuring robust clinical development planning and execution.
* Be a strong mentor for junior pharmacometricians and help in training activities
* Define and drive pharmacometrics contributions to regulatory/submission strategy and related documents (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, responses to Health Authority questions).
* Represent PMX on all pharmacometrics aspects of the programs at global regulatory hearings/advisory committee meetings and other global regulatory interfaces.
* Drive and coordinate the synthesis and integration of pharmacometrics information to support transition of drug development milestones / decision boards. Identifies alternative strategic options to mitigate risk on (early/full) clinical programs.
* Ensure that the Analytics team (biometrician, data management, database programming, programming, medical and scientific writing) are aligned on the pharmacometrics strategy, execution and delivery of assigned projects.
* May manage portfolio at disease area/therapeutic area/indication level to support integration of pharmacometrics and relevant (target, compound, disease) knowledge in the planning and execution of robust development programs and strategies, under the supervision of the PMX Development Unit leader
This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require 1% travel as defined by the business (domestic and/ or international).
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.
What you'll bring to the role:
* Ph.D. in Pharmacology, Biology, Engineering, Mathematics, Statistics, or a field with significant modeling-related content (or equivalent) with 6+ years modeling related activity in mathematical /statistical modeling with strong working knowledge / experience with R / MATLAB / NONMEM / Monolix.
* Proven ability for innovative problem solving, strong fundamentals in mathematical modeling, collaboration skills across functional areas and good communication skills to both quantitative and non -quantitative scientists.
* Demonstrated experience in showing leadership skills and results oriented performance in challenging projects, collaborations with internal and external partners, and health authorities.
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 email@example.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.
Global Drug Development
Research & Development
Keywords: Novartis Group Companies, Cambridge , Associate Director, Pharmacometrics, Executive , Cambridge, Massachusetts
here to apply!