Associate Director / Director Pharmacometrics

285753BR
Associate Director / Director Pharmacometrics

Job Description

Associate Director / Director Pharmacometrics

85 quantitative scientists in Novartis are supporting more than 80 clinical development projects in 10 therapeutic areas every day, who transform clinical data into analyses that build the basis for making innovative drugs accessible for patients. Quantitative scientists in pharmacometrics collaborate with cross-functional international teams and develop models characterizing exposure-response, disease progression, biomarker and diagnostic assays. These models allow optimal decision making on key development questions such as dose selection and treatment.
Come to an industry leader where you will have the opportunity to provide quantitative support for early and late clinical drug development. The successful candidate will drive and/or supervise the pharmacometric strategy for early and full clinical programs in multiple indications or a disease area. You will be responsible for performing, or driving, or supervising execution of the pharmacometrics strategy in those programs to optimize drug development. You will set the strategy for addressing pharmacometric issues in regulatory submissions and directly influences drug development decisions with internal and external partners. The role requires that s/he should have diverse modeling experience in drug development within pharma/biotech and a strong track-record of scientific and collaborative leadership in projects and initiatives.

Accountabilities
•Represent the Global Project Teams internally and externally as the pharmacometrics expert, including regulatory interactions.
•Lead the PMX contributions to the integration of relevant technical and disease area knowledge in the planning and execution of robust development programs.
•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). Interact 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 team in-licensing opportunities.

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.

Minimum requirements

Position will be filled at level commensurate with experience

(May be hired at the Associate Director and Director levels)

Education
PhD or PharmD in Pharmaceutical sciences, Clinical pharmacology, mathematics, statistics, engineering or other quantitative discipline preferred

Experience
•Associate Director – PhD with 6+ years’ experience; Director – PhD with 8+ years’ experience in modeling and core expertise 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, pharmacological, statistics and therapeutic knowledge in one or more disease areas
•Diverse experience in pharma industry on incorporation of Modeling & Simulation 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 and concise presentations for both internal and external meetings in key decision making situations

Why consider Novartis?

750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.
Global Drug Development
CD&A GDD
USA
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time
Regular