1+ months

Manager, Clinical Studies R&D; Pharmacokinetics/Bioequivalence

Parsippany, NJ 07054
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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

The Manager, Clinical Studies R&D will be responsible for the delivery of bioequivalence (BE) studies in support of generic product development for US FDA submission. The Manager, with the support of the Director, will be responsible for the design, management, and reporting of bioequivalence studies for all dosage forms in which he/she is assigned. Studies include healthy PK (pharmacokinetic) studies and patient PK studies.

General duties and responsibilities

  • To collect comprehensive pharmacokinetic information in conjunction with the Director for potential drug candidates to be included into the companys development program and to prepare Pharmacokinetic Evaluations if applicable
  • To attend team meetings and provide clinical support to the Salt Lake City and Larne sites, as well as other sites, where applicable.
  • To design BE studies according to current standards and guidance applicable to conduct of BE studies/clinical studies
  • To prepare and maintain the Sponsor Trial Master File (TMF) for each clinical study the Clinical R&D Manager becomes responsible for
  • To review the clinical protocol and to review and approve Informed Consent Forms (IFCs) and Case Report Form (CRFs) for BE studies/clinical studies
  • To work with the CRO to ensure that all deliverables are received as per the agreed upon timelines
  • To compile information in support of Clinical Trial Applications (CTA) and Import License applications and to send them to the concerned Clinical Research Organizations (CROs)
  • To supervise and coordinate various study related tasks from study initiation to closure
  • To arrange for handling, storage and retention of the Investigational Medicinal Products (IMPs), e.g. test and reference products
  • To ensure that the IMPs intended for use in BE studies/clinical studies are labeled in accordance with the Annex 13 to GMP and local requirements where the study will be conducted
  • To ensure timely shipping of the IMPs to the CRO/clinic site
  • To ensure monitoring of BE studies for which the Manager, Clinical R&D is responsible
  • To review and approve clinical study reports
  • To assist in the response to deficiency letters from authorities and audit comments
  • Any other related tasks as may be required from time to time
Qualifications
  • Bachelor's Degree in the field of Pharmacy, Chemistry, Health and Science or any related fields
  • 5 + years experience in BE studies/clinical studies is preferred, particularly for transdermal dosage forms and other complex products
  • 5 + years experience with GCP (Good Clinical Practice) , GLP (Good Laboratory Practice) and ICH (International Council for Harmonisation) guidelines and other guidelines applicable to conduct bioequivalence (BE) studies/clinical studies
  • Knowledge of basic statistical principles and their application to BE/PK studies
  • Able to plan, organize, coordinate and manage tasks efficiently
Function
Research & Development
Sub Function
Clinical Development
Reports To

Director of Clinical R&D

Tevas Equal Employment Opportunity Commitment
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.

Posted: 2019-10-02 Expires: 2020-01-07

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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Manager, Clinical Studies R&D; Pharmacokinetics/Bioequivalence

Teva Pharmaceuticals
Parsippany, NJ 07054

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