The Pharmacometrician is responsible for developing the PMX strategy of the projects assigned to. In this capacity the incumbent is responsible for the construction, validation, and implementation of disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with Clinical Pharmacologists and other R&D partners.
Essential Areas of Responsibility
Lead the design and execution of Model Based Drug Development strategy using quantitative approaches to address complex questions arising during drug development
Manage and perform pharmacometric analyses done internally and/or by external vendors using a variety of tools and approaches. Integrate, interpret, and report results to project teams and other customers.
Proactively contribute expert input into key pre-clinical, clinical, and regulatory documents including clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND and NDA's within agreed timelines, and meeting all regulatory requirements in consultation with manager.
Ensure constructive collaboration within drug development teams and with other internal partners (e.g. DMPK, Regulatory Affairs, Clinical Development, and Biostatistics).
Monitor timelines, objectives and, budgets. Ensure accuracy of project and activity progress. Assure rapid and effective communication of high-quality data and results to project teams.
Maintain and enhance technical and drug development expertise (e.g. training courses, external meeting attendance). Initiate training / study sessions within Teva’s Clinical Pharmacology & Pharmacometrics and for other line functions. Act as technical subject matter expert in key clinical pharmacology / DMPK / pharmacometric related area.
Attend meetings with external parties including investigators, outside experts, and health authorities.
Strong quantitative skills and expertise (e.g. experience in mechanistic PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations)
PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Biostatistics, Biomedical Engineering
5-10 years of industry experience in pharmacometrics in clinical pharmacology and/or clinical PK/PD.
Excellent written and verbal communication skills
Demonstrated presentation skills. Ability to work in a complex multi-disciplinary and global environment.
Preferred: Experience in the following therapeutic area(s): neurodegeneration, movement disorders, pain, and respiratory is an advantage