Title: Clinical Program Leader
Salary: Highly competitive
After highly successful preclinical studies my client is looking for a Clinical Project Manager specializing in various therapeutic areas (for example oncology, inflammatory and others) to oversee Phase I and II oncology trials in Germany. You will be overseeing a small team of highly qualified individuals to deliver successful phase I trials.
Responsibilities of the Role.
- Essential core member of the Global Clinical Program team.
- Take part in writing the Clinical Development plan in assigned oncology indications. In conjunction with the Medical Director.
- Lead and mentor the CTTs in the execution of Clinical trials.
- Create and review the SOPs for the execution of the clinical trial.
- Serve as a point of contact for unexpected situations that arise due to the clinical trials.
- Take part in vendor governance meetings to address issues encountered by the clinical trials monitors
- Ph.D life sciences degree
- Proven record of scientific protocol writing in a Biotech
- 6-8 years' of clinical development experience across Phase I to III
- Experience in oncology or immunology diseases would be a plus
- Experience in international development required
- Experience of the regulatory rules for clinical operations
- Experience of writing research reports and FDA regulatory dossiers (IND, NDA) and EMA
- Hands on mentality
- Previous experience handling the clinical trial budget is essential.
- Proficient in English at a fluent level
- Based in Germany
- Salary & package to define according skills and experience
- Company offers a bonus
- Hybrid Model
If you or anyone you know is interested in this position please apply directly or reach out to me if you have any questions.