Clinical Development Scientist - Nuernberg, Deutschland - ITM Isotope Technologies Munich SE

ITM Isotope Technologies Munich SE

Geprüftes Unternehmen

Nuernberg, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 23 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 problemsolving 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?