Teva Director Pharmacometrics 

United States, Pennsylvania, East Bradford Township 

11744841

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

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.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.