Head of European Clinical Development - Critical Care
- Experience Level
I am currently collaborating with a rapidly expanding international corporation with a team of >250 individuals globally and a reach across >60 countries.
We are assisting the expansion of their European Clinical Development department, seeking a senior individual with profound experience within the fields of Cardiovascular, Intensive Care or Hepatology drug development.
If you have a passion for life-saving therapeutics and want to contribute to the latest developments within immunotherapy and intensive care medicine, please read further.
- In this position, you are responsible for the design, execution and reporting of clinical trials from early phase to pivotal studies, supporting approval according to the highest standards for ethics, scientific merit, and regulatory compliance
- Provide clinical and medical oversight of marketed products including pharmacovigilance.
- Drive medical affairs projects, including health economics.
- Execute leadership at scientific meetings and conferences.
- Drive the development of company-sponsored clinical trials in the U.S. and Europe
- Development of trial protocol and other related study documents.
- Lead the interactions with external stakeholders including regulatory agencies (e.g. EMA, FDA), advisory boards and study committees (Executive committee, DSMB, CEC, etc.).
- Under the direction of the CMO authors clinical trial reports, and academic outputs such as original abstracts and peer-review publications.
- MD – Expertise in Cardiovascular (Surgery, vascular), Intensive/Critical care, Pulmonology, Hepatology, Anaesthesiology or related area in a critical care environment
- PhD advantageous
- >10 years of international clinical development experience within industry
- Experience designing and conducting international clinical trials
- Experience interacting with Regulatory bodies including the EMA and FDA
- You are willing to work remotely but travel on regular basis (<30%)
- Experience working with Medical Devices highly advantageous
- Competitive basic salary
- Market leading bonus
- An exciting working environment within a dynamic company
- A stable employment contract of unlimited duration
- Remote working
- Long term stock option program
If you are interested, get in touch with me ASAP…
Adam J. Bloomfield
Senior Clinical Development and Medical Affairs Recruitment Consultant
Email: abloomfield (at) barringtonjames.com