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Director-Global Clinical Operations

Date: Jan 12, 2021

Location: West Chester, New Jersey, US, 19380

Company: Teva Pharmaceuticals

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!

 

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.  We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

Job Description

R&D:
Teva’s 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.
 

Joining our Teva team you will be responsibilities for:

  • Director, Clinical Operations (Biosimilars) will be responsible to develop the clinical efficacy study operational strategy for Biosimilar products.
  • Develop and present Biosimilar efficacy studies vendor and clinical strategy
  • Complete operational oversight of all Biosimilar efficacy studies
  • Management background in a Clinical Trials setting with the ability to service and engage with different stakeholders within the Teva Organization
  • Provide leadership to current clinical team for success and growth potential
  • Manage and maintain contracts/work order review to ensure objectives are met
  • Budget management (projections, accruals) in coordination with Clinical Study Manager
  • Review of key clinical trial documents/plans
  • Responsible for responding to regulatory queries in discussion with CROs/Clinical Lead
  • Ensure Study Timelines and Budget are met in a timely manner
  • You will be involved in Safety and Blinded data review meetings
     

 

Qualifications

 

Education:

  • Bachelor’s Degree in the field of Pharmacy, Chemistry, Biology, or any related Science field.

 

Your expertise will be added value to our team in the following areas:

• 20 plus years’ experience in pharmaceutical or clinical research related field
• Knowledge of Good Clinical Practice (GCP) and International Council for Harmonization (ICH) guidelines and other requirement relative to clinical study conduct.
• Experience in conducting global efficacy studies
• Experience with Biosimilar efficacy studies is added advantage but not mandatory
• Team management skills
 

Function

Research & Development

Sub Function

Clinical Trials Operations

Reports To

In process of validation

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.

Teva’s 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.


Nearest Major Market: Philadelphia