Preclinical Safety Lead (all genders)

Posted 17 Dec 2021

Darmstadt, Hessen - Germany

Req Id 236716

Details

 

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Your role:

We are seeking a highly motivated, team-oriented individual for a position in the global project strategy and science team within preclinical safety. You will be team member of multidisciplinary drug discovery and development teams and provide high quality expertise on preclinical safety (Toxicology and Safety Pharmacology). You are accountable for the preclinical safety 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 Company's Biopharma functions and Health Authorities. You contribute to activities for due diligence evaluations.

The position will be based in Ivrea, Italy or Darmstadt, Germany.

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 5 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
  • Fluency in English 

 

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

 

We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

 

Apply Now