Associate Director Pharmacometrics

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

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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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.