Associate Director Pharmacometrics
Date: Apr 7, 2021
Location: West Chester, Pennsylvania, US, 19380
Company: Teva Pharmaceuticals
Company Info
Job Description
As the Associate Director you will be 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.
You will 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. In addition you will 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.
Other Duties & Responsibilities:
- 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 clinical pharmacology, clinical team and with other internal partners (e.g. DMPK, Biostatistics, Discovery, etc).
- 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.
Qualifications
What you will bring to the role:
- PhD in Clinical Pharmacology, Pharmaceutical sciences. Pharmacology, Life sciences or Engineering
- Minimum 6 years experience in applying PMX to drug development programs
- Minimum 3 years of experience with outsourcing PMX projects and managing vendors/contractors
Preferred Qualifications:
- Excellent knowledge of drug development process
- Global/international experience, including ability to manage intercultural regionally based teams
- 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
Function
Sub Function
Reports To
Senior Director, Pharmacometrics
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