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Required! – Associate Director (Pharmacometrics)
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Associate Director Pharmcometrics

About the Job

Job ID 156828BR
Posting Title Associate Director Pharmcometrics
Division PHARMA
Business Unit Global Develop NPH
Country USA
Work Location East Hanover, NJ
Company/Legal Entity Novartis Pharmaceuticals
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Job Description The Associate Director Pharmacometrics Scientist is the global lead for the planning, execution and delivery of pharmacometric strategy for multiple indications and/or a disease area (or equivalent) within (pre/early/full) clinical development. S/he is responsible for the design and implementation of pharmacometric model based methodologies that optimize the drug development program for each indication or disease area. S/he sets the strategy for addressing pharmacometric issues in regulatory submissions and directly influences drug development decisions with internal and external partners.
1. Quality and timeliness of pharmacometrics contribution in the implementation of robust, high quality research or development projects (including design, execution and delivery), including interactions with Health Authorities as assessed by the respective team members and/or by the AQS Franchise Head. 2. Pro-active disease area level innovation and presentation of pharmacometrics in the Project Teams/GPT/CDU, as assessed by the respective (pre/early/full-) Clinical Program lead and/or by the AQS Franchise Head. 3. Independent application of high quality pharmacometric methodology across the multiple indications/therapeutic areas including innovative designs, integrated disease area understanding, and Health Authority acceptability as assessed by the respective (pre/early/full-) Clinical Program lead and/or by the AQS Franchise Head. 4. Strong AQS team dynamics to support robust (pre/early/full-) Clinical Program as assessed by team colleagues. 5. Effective coaching and development of other pharmacometrics scientists, as assessed by the AQS Franchise Head.
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.
Minimum requirements Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent Ph.D. / MD). Fluent in English (oral and written). 1. 8+ years industry experience. 2. 4+ years in applying model based methods in pre-clinical and clinical drug development. 3. Track record of contributions to external white-papers/policy shaping best practice in pharmacometrics. Internally and externally established track record of developing/establishing pharmacometrics excellence. Experience in contributing to global scientific improvement/change initiatives. 4. Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development. 5. Record of interaction with regulatory agencies. 6. Clinical, pharmacological and therapeutic knowledge of at least one disease area. 7. Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence. 8. Scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies. 9. Excellent communication and presentation skills and in particular the ability to effectively represent pharmacometrics issues to clinical teams. 10. Good business ethics.

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