Experienced Clinical Trial Manager Biologics (m/f)
We are looking for an experienced, enthusiastic and creative
Clinical Trial Manager Biologics
Your key responsibilities include:
- Oversee early phase clinical trials for novel virus-based therapeutics performed by CROs under ViraTherapeutics’ sponsorship including schedule and budget for clinical trial execution and ensure clinical trials are conducted in accordance with ICH GCP Guidelines, the Declaration of Helsinki and national regulations.
- Manage clinical trial preparation and progress
- Counsel and guide Contract Research Organizations (CROs)
- Establish or review trial related documents and reports
- Plan and monitor study budget and timelines
- Ensure timely submission to Ethics Committees and Competent Authorities
- Supervise monitoring activities and perform co-monitoring visits
- Organize and conduct investigator meetings
- Communicate all relevant and critical issues to the senior management in a timely manner
- Work in close collaboration with team members and international partners
Your ideal qualification:
- MD or PhD in Life Sciences with sound medical knowledge, at least 5 years of professional experience in clinical trials management in a pharma/biotech setting. Expertise in the area of oncology, immunotherapy and/or virology/gene therapy is a strong plus. Experience with first-in-man trials is an asset.
- In-depth knowledge of international and national/regional guidelines and regulatory topics
- Excellent organizational and project management skills and an aptitude for writing
- Leadership potential, working in a proactive manner with hands-on approach
- Strong team player with excellent communication skills and willing to work in an environment where individual initiative and accountability to the team are required
- The position requires excellent verbal and written communication skills and fluency in both, English and German.
- Ability to travel 10-20% of time
- You will have the responsibility oversee ViraTherapeutics’ clinical trials from initial discussions through to the final study report. For that you have access to all talent in the company you need.
- Your workplace is preferably in our premises in Innsbruck; however, as long as presence in Innsbruck for 1-2 days per week is possible, your workplace can be anywhere else within suitable distance.
- This position is remunerated with a combination of fixed salary, bonus and equity. Our candidate of choice will convince us that a base annual salary of 80.000 Euro is not enough.
ViraTherapeutics is based in the beautiful city of Innsbruck, Austria – a great place to live and to work.
Please contact: ViraTherapeutics GmbH, Frau Verena Hausen, Exlgasse 20a, 6020 Innsbruck, Austria
While applying for the job please refer to jobvector and use the following reference number: CTM2810
Frau Verena Hausen
About ViraTherapeutics GmbH
ViraTherapeutics GmbH is a privately held biopharmaceutical company that is developing promising innovative virus-based immunotherapeutics for the treatment of cancer. ViraT was founded in 2013 as a spin-out of the Medical University of Innsbruck, (Austria), by Prof. Dr. Dorothee von Laer, head of the Virology Division at the University. ViraT develops oncolytic cancer vaccines based on a...More about ViraTherapeutics GmbH