Senior Development Project Representative

Posted 23 May 2019

Darmstadt, Hesse - Germany

Req Id 191888

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:

You provide high quality expertise on preclinical safety (Toxicology and Safety Pharmacology) to Global Product Teams (GPTs). You are accountable for the management of pharma projects (small molecules and biologics) beginning at Exploratory Development (ED) through marketing authorization and life cycle management (LCM). You analyze results of in silico, in vitro and in vivo toxicology as well as of safety pharmacology studies and bibliographic data, put it into strategic perspective and create preclinical safety assessments. Furthermore, you compile preclinical safety parts of all regulatory documents including clinical trial applications (IND/IMPDs), global marketing authorization applications (e.g. BLA/NDA) and other filings. You support the delivery of high quality contributions to incoming requests from other Biopharma functions and Health Authorities. You contribute to activities for due diligence evaluations.

 

Who you are: 

  • Advanced scientific degree, DVM; PhD in life sciences (Toxicology, Biology, Physiology)
  • Toxicology Board (ABT) certification or certification in Pharmacology and Toxicology advantageous
  • At least 10 years experience within a pharmaceutical project environment
  • Detailed knowledge of preclinical toxicology and safety pharmacology, R&D processes and regulatory requirements
  • Broad experience in health authority interactions
  • Very good project management and analytical skills
  • Fluent in English; German advantageous

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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