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.
Lead the AQS contributions to the integration of relevant technical and disease area knowledge in the planning and execution of robust development programs. 2. Represent the Franchise internally and externally as the pharmacometrics expert, including regulatory interactions 3. As partner to senior leadership (Global Brand Medical Directors/ Translational Medicine Heads), provide pharmacometric leadership in the quantitative evaluation of competing trial/analysis strategies assuring robust support to clinical development planning and execution and alignment with CDPs/TPPs. Leads and facilitates teams in the definition and quantitative evaluation of competing programs/trials/analyses with particular emphasis on pharmacometrics issues. 4. Lead and optimize the provision of pharmacometric contribution to regulatory/submission strategy and related documents: (e.g.: Target Product Profile, sPoC document, CDP, Briefing Books, Risk Management Plan and responses to HA questions). Interact with Health Authorities and external key opinion leaders as the recognized Novartis pharmacometrics expert within the Franchise (or equivalent). Represent AQS at global regulatory hearings/advisory committee meetings and other global regulatory interactions. 5. Anticipates franchise needs based on in-depth understanding of the relevant pharmacometrics issues. Identify opportunities, advocate and drive the integration and implementation of modern aspects of drug R&D with particular emphasis on pharmacometric methodologies across the major drug development milestones. 6. Foster the integration of pharmacometric methodology into development programs, and ensure that the IIS/AQS team (biometrician, data management, database programming, programming, medical and scientific writing) are aligned on the pharmacometric strategy, its execution and delivery. 7. Identify and lead next generation opportunities for infrastructure / process / scientific consulting improvement initiatives 8. Provide technical pharmacometrics expertise, leadership and education. Serve as a role model and mentor to associates.
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, computational science, or a field with significant modeling-related content (or equivalent Ph.D. / MD) English 10+ years industry experience 2. 6+ years in applying, and mentoring model based methods in pre-clinical and clinical drug development. 3. Track record of identifying and leading contributions to external white-papers/policy that shape best practice in pharmacometrics. Has internally and externally established track record of developing/establishing pharmacometrics excellence. Record in contributing to scientific improvement/change initiatives. 4. Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development 5. Evidence of consulting skill in the drug development context, i.e. within project teams and management boards 6. Record of interaction with regulatory agencies. 7. Clinical, pharmacological and therapeutic knowledge in one or more disease areas 8. Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs integrating quantitative sciences, strong disease area knowledge
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