The opportunity
Responsible for the design and implementation of PMX strategy on the program level; 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 TS colleagues and other R&D partners.
Essential Duties & Responsibilities:
Lead design and implementation of the PMX strategy and other advanced Model Informed Drug Discovery and Development approaches (within and/or across programs) to enable quantitative decision making thorough the drug development cycles
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 into key pre-clinical, clinical, and regulatory documents including; clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND and BLA/NDA's within agreed timelines, and meeting all regulatory requirements.
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 internal and external parties including stakeholders, investigators, outside experts, and health authorities
Travel Requirements:
• Ability to travel with overnight stays, as required
Position will be based out of West Chester, PA and candidate should be able to work onsite. Open to candidates working out of the Parsippany, NJ office as well.
Your experience and qualifications
Requirements:
PhD in clinical Pharmacology/Pharmaceutical sciences/pharmacology/Statistics/engineering with academic training in Pharmacometrics
Minimum 10 years of hands on industry experience in Pharmacometrics
Preference:
Experience in more than one therapeutic area and early development
Technical Knowledge:
Strong quantitative skills and expertise (e.g. experience in mechanistic PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations)
Excellent knowledge of drug development process.
Communication and presentation skills.
