A career with EMD Serono is an ongoing journey of discovery: our 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. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
To 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). To analyze results of in silico, in vitro and in vivo toxicology as well as safety pharmacology studies and bibliographic data, put it into strategic perspective and create preclinical safety assessments.
You will 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. To support delivery of high-quality contributions in incoming requests from other functions within the organization and Health Authorities. You will contribute to activities for due diligence evaluations.
Who you are:
- Bachelor’s degree with 8+ years of experience, master’s degree with 3+ years of experience, or PhD degree in biology, chemistry, pharmaceuticals, or related field
- Advanced scientific degree, DVM, PhD in life science (Toxicology, Biology, Physiology) preferred
- Toxicology Board (ABT) certification or certification in Pharmacology and Toxicology advantageous
- At least 10 years’ experience within a pharmaceutical project environment preferred
- Detailed knowledge of preclinical toxicology and safety pharmacology, R&D processes and regulatory requirements
- Broad experience in health authority interactions
- Excellent project management and analytical skills
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
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.