Clinical Development and Operations is the most important part of growing biotechs. It is the difference between helping millions of people on time or making them wait years.
The FDA / EMA and people across the world rely on how safe and how robust clinical trials are conducted. Our client is relying on you to support their rare diseases platform.
Their main products are used to cure several rare diseases, such as von Willebrand disease (VWD), hemophilia, hereditary angioedema (HAE), primary immunodeficiency (PID) and others
If you would like to join their mission and to work alongside some of the best medical experts and scientists then continue reading.
As a Clinical Scientist you will be responsible for;
* Significant work with all Clinical Development areas ( I-III ) with a focus in patient safety, trial design, site activation and documentation.
* With the team select and engage key clinical study sites/centers and establish and maintain collaborative relationships with key investigators.
* Ensure that Clinical Development Standard Operating Procedures (SOPs) facilitate the development of effective clinical study protocols and are compliant
* Develop/review/edit essential study documents such as protocols, medical monitoring plan, and medical data reviewing plan, case report forms, database specifications, and statistical analysis plan.
* Provide medical input in all essential documents, including, investigator brochure, clinical study reports, IND and NDA summary documents safety annual reports
* Support clinical research development and implementation of the study protocols, clinical trials and start-ups all within the defined project scope, budget and timeline
* Provide clinical research data to support EMA / FDA and other regulatory bodies and communicate across Medical, Commercial and Quality teams.
As a Clinical Scientist you will need;
* Scientific Degree background
* Protocol Experience
* Previous work within Immunology, Rare Diseases and/ or Infectious Diseases
* Extensive work in clinical development and trial design.
* More than 5 years of industry experience
* Experience in Global Clinical Trials
* English fluent, German and French not needed but preferred
* Proven track record of most of the above job responsibilities or transferrable experiences.
* Competitive salary.
* Flexible working - this position can be 100% home based
* Friendly office space, coffee, tea, social events.
* Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
If you are interested in this mission, or in general would like to discuss your options in the Clinical Development and Medical space then please send your CV in at or call me at +44 2038790716.
This is what the process will look like (note, this could change depending on you or the client's need);
1. Full call with the executive recruiter responsible.
2. Sharing of the company and confirmation by you to move forward.
3. Introductory call with the hiring manager.
4. Follow up call with the team (1 or 2 calls).
5. Face to face meeting.
This will be confidential and your CV will not be shared to anyone without your permission.
Please apply today or reach out confidentially.