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Clinical Development Scientist
vor 4 Monaten
**Your Role**:
- Support the ITM project Medical Lead(s) on early development and translational medicine studies (Phase I/II trials, clinical pharmacology and biomarkers studies)
- Contribute to study strategy and design, protocol concept, data analysis, interpretation and final study report ensuring consistency with the clinical development strategy
- Appropriately interact with Key Opinion Leaders (KOLs), collaborators, CROs, advisory boards, DSMB etc.
- Contribute to the medical monitoring activities of ongoing studies
- Ensure that high quality documents (protocols, IBs, ICFs, etc.) are developed in line with the Clinical Development Plan to effectively determine ITM radiopharmaceuticals efficacy and safety profile, as well as key areas of product differentiation and value to patient
- Participate in data management activities (eCRF development, data review and data cleaning) as well as in biostatistics activities (contributing to the statistical analysis plan and the dataset and data analysis specifications)
- Present the scientific rationale and study design at Investigator Meetings and respond to scientific questions arising from sites during study conduct
- Ensure prompt, quality communications with sites, Regulatory Agencies, Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Data Monitoring Committees (DMC), regarding protocol clarification and procedural queries
- Implement new business processes and strategies and also proactively identify issues and propose strategies to manage implications and risks on clinical study/Clinical Development plan
- Contribute to document writing for regulatory submissions, including scientific advice, IND/CTA, and NDA/BLA/MAA
- Contribute to study reports and publication/presentation of results
**What we are looking for**:
- Advanced life science degree (PhD, preferably MD), ideally in the field of clinical pharmacology or genomic profiling
- Ability to work in a hierarchically flat, matrix environment
- Minimum 2-3 years of professional experience as clinical scientist in a drug/biologic developing company, ideally in early clinical development setting (Phase I, clinical pharmacology trial, etc.)
- Strong working knowledge of the drug clinical development process, clinical trial design, medical monitoring, data management (including CDISC standards) and biostatistics
- Ability to understand, integrate, analyse and interpret clinical data
- Fluency in English
- Good management, interpersonal, communication, negotiation and problem-solving skills
**What we offer**:
- A modern workplace and exciting opportunities in an evolving and fast growing company
- Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
- A collegial corporate culture and short communication channels
- Flexible working hours with an attractive salary package and diverse corporate benefits
At ITM, we work together towards one common goal - the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion - the input of our multi-cultural employees makes us who we are.
Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than “maybe”.
Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment?
