Clinical Operations is the most important part of a growing biotech. 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 help develop their oncology platform.
With a focus on key cancer therapeutics, especially monoclonal antibody therapy, this biotech seeks to address high unmet need and effectively bring exciting solutions to the fore.
Cancer is responsible for millions of deaths each year with some being very difficult to treat - this biotech is using innovative approaches to try and change that.
If you would like to join their mission, to approach cancer in a novel way and work alongside some of the best medical experts and scientists then continue reading.
Please note this position is largely office-based.
As a Clinical Operations Manager you will be responsible for;
* Select and engage key clinical study sites/centers and establish and maintain collaborative relationships with key investigators.
* 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 operations manager you will need;
* Previous work within oncology- and ideally in monoclonal antibodies.
* Knowledge of ICH/GCP and other relevant regulations and guidelines
* Extensive work in clinical development and trial design.
* English fluent, German not needed but preferred
* Preferred previous work in the clinics, ideally with cancer patients.
* Proven track record of most of the above job responsibilities or transferrable experiences.
* Competitive salary.
* Flexible working.
* Friendly office space, coffee, tea, social events.
* Housing and child support if needed. Group pension plan.
* Working with some of the newest oncology treatments in Europe.
* 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 Operations space then please send your CV in , apply using the website link or contact me on . 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.