Biologist, Biochemist, Clinical Scientist as Clinical Operations Manager - Clinical Trials, Clinical Research, Oncology, Haematology (m/f)
Intl. Clinical Operations Manager (m/f) – full time.
In addition, you will drive the development of our further clinical development as well as regulatory strategy for Europe, the US, and Asia.
- Independent overall execution of a clinical trial in Chemotherapy- induced Neutropenia.
- Leading a small team of internal employees, external subject matter experts, investigators, and the CRO.
- Ensuring the cross-functional team’s compliance with SOPs, ICH-GCP and other applicable guidelines.
- Day-to-day management of clinical trial and project team.
- Managing quality of internal and external work deliverables, project timeline, and budget.
- Oversight of Trial Master File.
- Preparation of regulatory meetings especially with EU and US authorities.
- MD or PhD in Biology, Biochemistry, Clinical Science, or equivalent qualifications.
- At least 5 years of clinical research experience including 3 years of project/operation management experience.
- Experience in independently managing clinical trials under ICH-GCP.
- Experience in leading internal and external teams.
- Expertise of core clinical systems, tools, and metrics.
- Background in Oncology and/or Haematology is a plus.
- Good command of written and spoken English and at least good basic command of German.
- Experience in using MS Office applications.
- “But we have always done it like this” is not part of your repertoire.
Besides those requirements, we have a flexible home office policy.
If necessary, we can support you in obtaining a German work visa.
Please send your CV along with your expected salary and earliest date of availability.
We look forward to getting to know you!
While applying for the job please refer to jobvector
Att: Dirk Pleimes
Großenhainer Straße 227, 01129 Dresden
About Myelo Therapeutics GmbH
Myelo Therapeutics GmbH develops innovative treatments in areas of high unmet medical needs. Our lead compound prevents Chemotherapy-induced Neutropenia, the most common and most serious side effect of anticancer therapy. Myelo Therapeutics was selected 2014 as one of the “Top 40 High Tech Ventures of the East”. The company was founded 2013 and currently has 9 employees.More about Myelo Therapeutics GmbH