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Clinical Project and Operations Manager (m/f) - Berlin or Dresden

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Myelo Therapeutics:
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 5 employees.

To lead our clinical development department, we are looking for a Clinical Operations Manager (m/f) – full time.

What we offer: 
Myelo Therapeutics offers an attractive position in a challenging work environment and a lean and non-hierarchical organization. We give our employees a large degree of freedom to drive our scientific and commercial progress and to grow professionally. 
As a first project, you will independently lead a Phase I/IIa clinical trial in Chemotherapy-induced Neutropenia. For this trial you will manage an external Clinical Research Organisation and a small internal team.

Whom we are looking for: 
You are a good team player, experienced in independently managing clinical trials, ideally in the oncology / haematology field. You are well familiar with ICH-GCP guidelines. You are able to think out of the box and across functional boundaries, able to interact with and lead a diverse group of subject matter experts. A good sense of service, focus on high quality results, open and proactive communication, as well as an eagerness to learn new things make you a well suited candidate.

Your are of responsibility: 
  • 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.

Your profile:
  • MD or PhD in Biology, Biochemistry, Clinical Science, or equivalent qualifications.
  • Experience in independently managing clinical trials under ICH-GCP.
  • At least 5 years of clinical research experience including 3 years of project/operation management experience.
  • 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.
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!


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Details der Stellenanzeige

Gruppen- & Teamleitung
Berufserfahrung vorausgesetzt
Deutschland (Berlin, Sachsen)
01326 Dresden
Humanmedizin, Biologie & Life Sciences