Clinical Operations Manager
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 extensive Immuno-oncology platform.
With several key global partnerships supporting their development platform and recent huge cash investments this is promising to become one of the hottest ImmunoOncology biotechs in Europe.
Their key molecule is used in precision oncology treatments, priming immune responses to specific RNA nucleopeptides in the individual. This is having dramatic changes in people's lives - where once only extensive chemo (or no treatment) was available, they are changing this.
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.
As a Clinical Operations Manager you will be responsible for;
* With the team 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- either in Solid or Haematological.
* 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.
* Extensive Oncology and Haematology portfolio to work with including Immunotherapy, CART and other scientific approaches.
* 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 apply using the website link. 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.
Clinical Operations Manager