Novartis: 2 Pharmacometrics positions in Basel, Switzerland

Dear NMusers, 2 Pharmacometrics Scientist positions are now available in Basel, Switzerland. Please apply through the links below. Senior Principal Pharmacometrics Scientist https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?partnerid=13617&siteid=5260&jobid=2463555&_ga=1.268112330.577526406.1485269654 Job ID 204727BR Position Title Senior Principal Pharmacometrics Scientist Division Global Drug Development Business Unit Global Develop NPH Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description The Senior Principal Pharmacometrics Scientist leads the planning, execution and delivery of pharmacometric strategy on assigned projects within (pre/early/full) clinical development. S/he is responsible for the discussion and implementation of pharmacometric methodologies that optimally address the research and development objectives on the assigned projects. S/he provides pharmacometric support for regulatory submissions, and contributes to drug development decisions with internal and external partners. Major Activities: 1. Provide global strategic pharmacometric leadership and support to (pre/early/full-) clinical development projects, based on relevant technical and disease area knowledge. 2. Represent the GPT/GCT/CTT (or equivalent) internally and externally as the pharmacometrics scientist, including in regulatory interactions 3. In collaboration with Development counterparts (Global Brand/Project Medical Directors/ Translational Medicine Experts) and Global Project Teams/GCT/CTTs, provide pharmacometric support for the quantitative evaluation of competing trial/analysis strategies assuring robust support to clinical development planning and execution and alignment with CDPs/TPPs. 4. Develop, write and execute pharmacometric analysis plans, and deliver reports on results. 5. Drive the pharmacometric contributions 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). 6. Assess pharmacometric requirements for, and ensure integration of pharmacometric information into transition of drug development milestones / decision boards. 7. Align the IIS/AQS team (biometrician, data management, database programming, programming, medical and scientific writing) on the pharmacometric strategy, execution and delivery of assigned projects. 8. Interact with Health Authorities and external key opinion leaders as the recognized Novartis pharmacometrics expert at indication (or equivalent) level for all relevant aspects of the program. Represent AQS at across global regulatory hearings/advisory committee meetings and other global regulatory interfaces 9. Provide technical pharmacometrics expertise and identify opportunities for influencing internal discussions on white papers/regulatory policy. Minimum requirements Education and/or professional experience: Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent Ph.D. / MD) Languages: Fluent in English (Oral and written) Experience / Professional Requirements: 1. 5+ years industry experience 2. 2+ years in applying model based methods in pre-clinical and clinical drug development. . 3. Contributes to external white-papers/policy shaping best practice in pharmacometrics. Has established track record of developing/establishing pharmacometrics excellence. Experience in contributing to scientific improvement/change initiatives. 4. Good interpersonal and communication skills (verbal and writing) bridging scientific and business needs - integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence 5. Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development 6. Scientific skills demonstrated in facilitating the (pre/early/full-) clinical development strategy. 7. Clinical, pharmacological and therapeutic knowledge of at least one disease area 8. Strong skills to facilitate and enable the contribution of quantitative teams Principal Pharmacometrics Scientist https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?partnerid=13617&siteid=5260&jobid=2463553&_ga=1.227856729.577526406.1485269654 Job ID 204726BR Position Title Principal Pharmacometrics Scientist Division Global Drug Development Business Unit Global Develop NPH Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description The Principal Pharmacometrics Scientist leads the execution and delivery of pharmacometrics tasks on assigned projects within (pre/early/full) clinical development. Together with the AQS franchise leadership, s/he is responsible for the discussion and implementation of pharmacometric methodologies that optimally address the research and development objectives on assigned projects. 1. Provide pharmacometric support for assigned projects, and proactively seek the support and input from senior AQS colleagues and AQS franchise leadership. 2. In collaboration with Research and Development team members, AQS Franchise Head and senior AQS associates, negotiate and develop (pre/early/full) clinical trial objectives and pharmacometric deliverables. 3. In collaboration with partners in (pre-/early/full) clinical development teams (Medical Scientific Expert/Global Program or Brand Medical Directors/ Translational Medicine Experts and AQS Franchise head), provide pharmacometric support for the quantitative evaluation of competing trial/analysis strategies assuring robust support to clinical development planning and execution and alignment with CDPs/TPPs. 4. In collaboration with AQS franchise leadership write and execute modeling plans, and deliver reports of results. 5. Contribute to the pharmacometric scientific content of materials for internal decision boards/regulatory/submission documents: Briefing Books, decision criteria, trial design(s), responses to trial-specific Health Authority questions. 6. Align the IIS/AQS team (biometrician, data management, database programming, programming, medical and scientific writing) on the pharmacometric strategy and execution on assigned projects. Minimum requirements Education and/or professional experience: Ph.D. in pharmacology, biology, engineering, computational sciences, mathematics, statistics, or a field with significant modeling-related content (or equivalent Ph.D. / MD) Languages: Fluent in English (Oral and written) Experience / Professional Requirements: 1. 2+ years modeling related activity relevant to the role as a pharmacometrician 2. Strong working knowledge / experience with SAS/ R/ Splus MATLAB / NONMEM / Monolix or any other business or research analytic software relevant to pharmacometrics. 3. Good interpersonal and communication skills bridging scientific and business needs 4. Good scientific leadership skills demonstrated in facilitating the inclusion and execution of pharmacometrics methods. 5. Good team player skills to enable and participate in the contribution of quantitative teams Gordon Graham Pharmacometrics Novartis Pharma AG Postfach CH-4002 Basel SWITZERLAND Phone +41 61 3246253 Mobile +41 79 3959364 Fax +41 61 3241246 [email protected]<mailto:[email protected]> http://www.novartis.com/