US-MA, Principal Fellow / Senior Fellow Pharmacometrics 201952BR-MZ
Principal Fellow / Senior Fellow Pharmacometrics
Global Drug Development
Global Develop NPH
Research & Development
The Principal Fellow / Senior Fellow supports oncology drug development by providing clinical pharmacology/DMPK/pharmacometric expertise across early and full development phases, and global medical affairs, with a Pharmacology Focus or a Pharmacometrics Focus or some mixture thereof. Supports project teams with modeling- and simulation-based input to program strategies and trial design, evaluations, integrated analysis, and reporting.
1. Perform and oversee pharmacometric analyses using a variety of tools and approaches.
Integrate, interpret, and report data to project teams and other customers. Create, advocate, and implement innovative program strategies.
2. Lead the pharmacometric strategy and coordinate activities across projects. Server as mentor for junior pharmacometricians and pharmacologists.
3. Proactively contribute expert input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, modeling reports, investigator bro-chures, IND / IMPD's and NDA's within agreed timelines, and meeting all regulatory require-ments in consultation with manager.
4. Ensure constructive collaboration within drug development teams (GPTs, etc) and with other internal partners (e.g. DMPK, Toxicology, Formulations, Drug Regulatory Affairs, Clinical Development).
5. Define and update as appropriate the PK, PK/PD, DMPK, biopharmaceutical and pharmaco-metric requirements in the OCP and/or preclinical project development plans.
6. Monitor timelines, objectives and, as appropriate, budgets. Ensure accuracy of project and activity progress in company tracking tools (e.g., Succeed, ModTracker). Assure rapid and ef-fective communication of high-quality data and results to project teams.
7. Follow internal processes, adhere to Novartis and project-specific standards and, when re-quired, adhere to Health Authority requirements (SOPs, Master Analysis Plan, GCP, and regu-latory guidelines). Lead initiatives for creating and updating new processes and standards for OCP.
8. Lead or participate in OCP or project sub-teams. Coordinate with appropriate sub-team members and/or prepare summary documentation
9. Maintain and enhance technical and drug development expertise (e.g. training courses, exter-nal meeting attendance). Initiate training / study sessions within OCP and for other line func-tions. Act as technical subject matter expert in key clinical pharmacology / DMPK / pharma-cometric related area.
10. Attend meetings with external parties including investigators, outside experts, and health au-thorities.
11. Coach and mentor other OCP 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 a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent experience.
Fluent English (oral and written)
1. Relevant postdoctoral, academic, industry, or government experience (9-15 years for Principal Fellow, 6-10 years for Senior Fellow)
2. Integrated knowledge of pharmacometric tools (e.g., WinNonlin, SAS, NONMEM, Trial Simulator, GastroPlus, SymCyp).
3. Integrated knowledge of related disciplines (e.g., DMPK, biostatistics, toxicology, regulatory) in the drug development process.
4. Demonstrated experience and ability to work successsfully as part of cross functional teams in a highly dynamic, matrixed, project-team environment.
5. Excellent oral and written communication skills.
6. Excellent organizational and project skills.
7. Excellent critical thinking and problem solving skills, including publications / presentations.
8. Strong influencing and negotiating skills.
9. Strong coaching, mentoring, and people management skills.
****Position will be filled commensurate to experience****
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