Principal Pharmacometrics Scientist, Pharmacometrics M&S

Job description

Job Description

Conduct research dealing with the understanding of human diseases and the improvement of human health. Provide pharmacometric/modeling support as assigned in immunology and dermatology therapeutic areas with the special focus on rheumatology indications, to quantify drug, disease and trial information to aid efficient drug development, regulatory decisions and rational drug treatment in patients. Scope and plan pharmacometric/modeling tasks on assigned projects. Lead execution and delivery of pharmacometric/modeling tasks within pre-, early and full clinical development. Plan and apply pharmacometric/modeling methods, including population pharmacokinetics and pharmacokinetics-pharmacodynamics using nonlinear mixed-effects modeling and simulation, across all phases of clinical development with regard to optimal use of designs and decision making. Utilize R, MATLAB, NONMEM and Monolix for hands-on pharmacometric/modeling deliverables. Contribute to pharmacometric/modeling scientific content of materials as required for internal decision boards / regulatory / submission documents: Briefing Books, decision criteria, trial design, responses to trial-specific Health Authority (HA) questions. Write and execute Modeling Plans and summarize results in Modeling Reports, as key pharmacometric/modeling deliverables for HA submissions. Actively participate in initiatives for improvement of pharmacometric/modeling infrastructure. Contribute to methodology, process and training material improvement. Establish relationships in the scientific community and serve as an advocate for Novartis Pharmacometrics Modeling & Simulation group. Exercise effective communication for bridging between scientific and business needs.

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 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.

Desired profile

Minimum requirements

Principal Pharmacometrics Scientist, Pharmacometrics M&S sought by Novartis Pharmaceuticals Corporation for East Hanover, NJ location. Must have PhD or foreign equivalent degree in Pharmacology, Biology, Computer and Information Science, or Computational Sciences, and minimum 2 years of industry experience in pharmacometric/modeling support and hands-on input for clinical development in immunology and dermatology therapeutic areas, with special focus on rheumatology indications; exposure to pre-, early and full clinical development stages; with strong working knowledge and demonstrated expertise in R, MATLAB, NONMEM and Monolix analytic software platforms; applying pharmacometric/modeling methods such as population pharmacokinetics and pharmacokinetics-pharmacodynamics; authoring Modeling Plans and Modeling Reports for HA submissions; contributing to methodology, process, infrastructure and training material improvement. Must have demonstrated success in working with clinical development and cross-functional teams, and communication to bridge scientific and business objectives. Respond to NPC, Attn: K. Oakley Req 205254BR, Bldg 110 Rm 244, 1 Health Plaza, East Hanover, NJ 07936-1080 or online www.novartis.com/careers. Novartis is an EOE.