Clinical Research Scientist
An opportunity has opened for an experienced Clinical Research Scientist to join a fast-paced Biotech company based in Munich within their global oncology development team. The company have a solid pipeline in oncology for an organisation of their size which is perfect for an individual who is looking to progress quickly within their career.
This role requires office-based working of 1 or 2 days per week in Munich post Covid, but the team will be flexible on this for the right candidate. Relocators are also a consideration for this opportunity with relocation assistance being an option.
- Responsible for providing medical / scientific input and expertise to individual clinical trial(s) within a global development program of a disease area
- Represent Clinical Development in Clinical Trial Teams (CTT), participate and contribute in clinical subteams and other committees needing medical support
- For the assigned clinical trial(s) within a program, as a member of the CTT, provide medical and scientific input to: all activities related to planning, execution and reporting of clinical trials; development of trial related documents (e. g. protocols, case report forms, data analysis plan, reports, publications); development of presentation material for trial-related advisory boards, investigator meetings, protocol training, etc.
- Ongoing review of clinical trial data, final analysis and interpretation, in collaboration with the Safety Leader and appropriate CTT members.
- Build relationships among the clinical/scientific community and with external experts
- Maintain sponsor oversight on data quality and product safety in clinical trials via regular medical monitoring activities in collaboration with the Safety Leader and appropriate Clinical Trial Team members. Perform hands on medical data review, as needed.
- Support regulatory authority interactions, information requests etc (e.g. FDA and EMA) as needed
- Based on individual expertise, perform evaluations of potential drug targets and drug candidates for future clinical development
- No people management responsibilities
- Ideally PharmD or PhD in health sciences / translational research with substantial experience in clinical development and clinical research
- Strong background in haemato-oncology, oncology or immuno-oncology
- Experience in early and/or late drug development (Phase 1-3)
- Ideally at least three years of relevant professional experience, ideally in the pharmaceutical or biotechnology industry
- Prior experience in regulatory authority interactions / submissions preferred but not a must
- Ability to critically evaluate drug targets or drug candidates based on published data or preclinical research findings and to translate these findings into clinical hypothesis testing
- Excellent medical writing and presentation skills
- Strategic thinker
- Proficient in written and spoken English is a must
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.