30 days old

Senior Manager Pharmacometrics

West Chester, PA 19380

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

Tevas Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.

 

You will be reporting to Senior Director of Pharmacometrics. You will be responsible for 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 as a member of the team:

  • Lead the execution of Model Based Drug Development strategy using quantitative approaches to address complex questions arising during drug development.                                
  • Perform pharmacometric analyses e.g. population PK, PKPD-analyses, clinical trial simulations and other model based analyses. Manage pharmacometric analysis conducted by external vendors. Integrate, interpret, and report results to project teams and other customers. 
  • Proactively contribute expert input into key pre-clinical, clinical, and regulatory documents including clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND and NDA's within agreed timelines, and meeting all regulatory requirements in consultation with manager.                                                                   
  • 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 Tevas Clinical Pharmacology & Pharmacometrics and for other line functions
     

Ability to travel with overnight stay as needed.

Qualifications

What you will bring to the role:

  • PhD or equivalent in Pharmaceutical Sciences, Clinical Pharmacology, and Chemical/Biomedical Engineering
  • Minimum 2 years of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics.

 

Preferred Qualifications:

  • Experience in more than one therapeutic area and early development 
  • Proficiency with pharmacometric tools such as NONMEM, R, Monolix, and Phoenix WinNolin.
  • Experience in change management. Global/international experience, including ability to manage intercultural regionally based teams.

Function

Research & Development

Sub Function

Biometrics

Reports To

Senior Director Pharmacometrics

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

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.

Categories

Posted: 2021-04-06 Expires: 2021-05-30

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Manager Pharmacometrics

Teva Pharmaceuticals
West Chester, PA 19380

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