US-MA, Director Pharmacometrics Scientist 195382BR-MZ
Director Pharmacometrics Scientist
Global Drug Development
Global Develop NPH
Research & Development
The Director Pharmacometrics Scientist drives pharmacometric strategy at Franchise and/or disease area level in (pre/early/full) clinical development programs. S/he is responsible for driving the design and implementation of pharmacometric methodologies that help optimize drug development programs at the Franchise and/or disease area level. S/he serves as a consultant to the Franchise level leadership on strategic and regulatory pharmacometrics issues across all stages of development.
The Director Pharmacometric Scientist role involves leading at a global level the planning, execution and delivery of modeling and simulation strategy for multiple indications and/or a disease area (or equivalent) within (pre/early/full) clinical development. Requires the candidate to have expert knowledge and domain expertise in certain modeling areas and also strong therapeutic area expertise in 1-2 disease indications. They will also be expected to be capable in developing collaborative relationships and strategic plans across programs in a therapeutic area. Responsible for the design and implementation of pharmacometric methodologies that optimally address the research and development objectives on the assigned projects. Sets the strategy for addressing pharmacometric support for regulatory submissions, and directly influences drug development decisions with internal and external partners. In this role, the candidate is expected to identify the relevant development questions that would benefit from model-based methods and develop modeling plans to deliver meaningful and timely results clearly to development teams. The candidate must have excellent communication and interpersonal skills and the ability to work independently and effectively on interdepartmental project teams. They are also expected to have good mentoring skills to help less experienced associates and good collaborative skills with other quantitative disciplines including biostatistics.
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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent Ph.D. / MD) required.
8+ years industry experience required.
Candidates should have requisite expertise in quantitative pharmacology, strong hands-on modeling and simulation skills, and demonstrated impact on drug development through quantitative approaches experience.
Experience with mechanistic PK/PD and/or system pharmacology modeling is preferred.
Rich hands-on experience with NONMEM, Monolix, SPLUS, Matlab and/or other modeling and simulation software is required.
Experience working within clinical teams and contributing to (pre/early/full-) clinical development strategy with good strategic understanding for applying quantitative analysis at the appropriate time.
Strong clinical, pharmacological and therapeutic knowledge of at least one disease area required.
Established track record of publications/presentations in pharmacometrics.
Experience in contributing to scientific improvement/change initiatives.
Excellent interpersonal and communication skills
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