Company Info

Job Description

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 Clinical Pharmacology colleagues and other R&D partners.

Essential Duties & Responsibilities:
1. 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.
2. 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.
3. 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. 
4. Ensure constructive collaboration within clinical pharmacology, clinical team and with other internal partners (e.g. DMPK, Biostatistics, Discovery, etc). 
5. 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. 
6. 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.
7. Attend meetings with internal and external parties including stakeholders, investigators, outside experts, and health authorities.

Qualifications

Position Requirements:

Education Required:
 PhD in Clinical Pharmacology, Pharmaceutical sciences. Pharmacology, Life sciences or Engineering, with academic or industry training in Pharmacometrics
 Strong quantitative skills
Minimal Experience Required:
 6 to 10 years industry experience in applying PMX to drug development programs.
 Excellent knowledge of drug development process.
 Experience in early clinical development, as well as Health Authority submissions
Specialized or Technical Knowledge Licenses, Certifications needed:
 Hands-on experience with PMX analysis in the industry, expertise in modeling software including NONMEM and  R. Knowledge in Monolix and NMLE are an advantage
 Strong Expertise (e.g. experience in mechanistic PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, or clinical trial simulations) 
 Experience with outsourcing PMX projects and managing vendors/contractors
Company/Industry Related Knowledge:
 Global/international experience, including ability to manage intercultural regionally based teams and fluent English skills (oral and written).

Function

Sub Function

Reports To

Senior Director Pharmacometrics

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