Beschreibung
Safety Science Medical Director (m/f/d)
Reference: -en
Start: asap
Duration: 6 MM++
Main tasks:
- Develop timely and scientifically sound clinical safety portions of a Product Development Plan (PDP), develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
- Contribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans (e.g., Integrated Safety Management Plan (ISMP), RMP)
- Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
- Pharmacovigilance and Risk Management
Main qualifications
- Profound academic experience
- Specialty training and board certification or equivalent (current or past) required or completed MD degree and postgraduate training with profound clinical or academic experience
- Proficient drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry
- Demonstrated team leadership in industry or academic setting
- Experience in the principles and techniques of data analysis, interpretation and clinical relevance
- Experience publishing in a refereed journal preferred
- Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle
- Strong orientation towards cross-functional teamwork
- Effectively work with remote partners on a global team
- Excellent written and verbal English communication skills
Main advantages:
- You will work in an international environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Athina Hondroulidou
Referencenumber:
Make contact:
Email: