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Job ID 211710BR Position Title Senior Fellow, Clinical Pharmacology Division NIBR Business Unit Translational Medicine Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description • Contributes expert pharmacokinetic / DMPK input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, IND / IMPD’s and NDA’s within agreed timelines, and meeting all regulatory requirements under minimal guidance from manager. • Designs clinical pharmacology strategy for assigned program and coordinates pharmacokinetic/ / DMPK related elements for preclinical and/or clinical projects. Identifies potential project hurdles, suggests solutions and establishes contingency plans. Represents OCP on Global Program Team(s) or early project teamss.
• Performs or oversees PK and PK / PD analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers.
• Ensures constructive collaboration within drug development teams (GPTs, etc) and with other internal partners (e.g.ie. DMPK, Toxicology,Modeling and Simulation, Formulations, Drug Regulatory Affairs, Clinical Development).
• Defines and updates as appropriate the PK, PK/PD, DMPK biopharmaceutical and M&S requirements in the OCP and/or preclinical project development plans. 5)6) Monitors study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools (e.g.ie, Succeed). Assures rapid and effective communication of data to project teams.
• Leads or participates in OCP or project sub-teams. Coordinates with appropriate sub-team members and/or prepares summary documentation.
• Maintains and enhances technical and drug development expertise (e.g. training courses, external meeting attendance). May act as technical subject matter expert in key clinical pharmacologypharmacokinetic / DMPK related area. • Attends and/or contributes to meetings with external parties including investigators, outside experts, and /or regulatory/health authorities.
• May manage one or more junior OCP associates. Coaches and mentors other OCP associates. Minimum requirements • Ph.D. in pharmacokinetics, drug metabolism or a related discipline, or a Pharm. D. with appropriate post-doctoral training
• Fluent English (oral and written)
Experience/Additional desired skills:
• 6 - 10 years of relevant post doctoral, academic, industry or government experience
• Expert knowledge of related disciplines (e.g. DMPK, toxicology, regulatory) and the drug development process
• Demonstrated experienceusing in silico analysis tools (e.g. WinNonlin, SAS, NonMEM, Trial Simulator, GastroPlus, SymCyp)
• Demonstrated experience and ability to work successfully as part of cross functional team in a highly dynamic, matrixed, project team environment
• Excellent oral and written communication skills
• Strong organizational and project skills
• Expert critical thinking and problem solving skills including publications / presentations.
• Strong influencing and negotiating skills
• Coaching, mentoring, and people management skills