We are currently seeking full time a Manager Clinical Safety (d/f/m) to support our global multidisciplinary Clinical Sciences team. This position will be responsible for supporting the Pharmacovigilance (PV) and Medical Monitoring (MM) operations during clinical program implementation, clinical study start-up, execution, closeout, data collection and analysis, as well as reporting and supporting of regulatory filings of clinical trials in various oncological indications.
This position will actively participate as a member of the Inhouse Safety Team and perform PV and MM activities including, but not limited to creating and finalizing trial specific safety management and medical monitoring plans, reviewing safety sections in protocols, and liaising with stakeholders to ensure PV and MM operations supported by external service providers. You will work in Tübingen or Munich (Germany) or partly home based. This is a permanent position with development opportunities.
Your main responsibilities will include but are not limited to the following tasks:
- Establish and maintain functional plans in the area of PV and MM together with external service providers.
- Prepare and conduct trainings on safety related processes during Investigator Meetings as well as site initiation visits, for inhouse teams as well as contract research organizations.
- Prepare and organize safety review meetings, present relevant safety events, and compile meeting minutes.
- Contribute to the development, maintenance and implementation of controlled documents like SOPs and other process documents for clinical trials.
- Analyze safety related data in the eCRF or listings extracted from data bases to identify relevant safety events and to support data reconciliation.
- Develop and write brief narratives of significant adverse events in accordance with regulatory requirements.
- Ensure processes for PV and Safety Reporting are implemented and executed consistently throughout clinical studies.
- Support the collection of safety reports from clinical trials and collaborate with other departments (Clinical Operations, Medical Department, Data Management, Medical Writing, Regulatory) to ensure consistency with regulations and departmental goals and objectives.
You hold a master´s degree or PhD (preferred) in biology or clinical/ life sciences. A minimum of 3 years of experience with the conduct of clinical trials, profound GCP knowledge and a strong understanding of medical terminology is required. Knowledge of Pharmacovigilance and Safety Reporting as well as Medical Monitoring is an advantage. Your competence and experience and your excellent communication skills enable you to successfully contribute to a constantly growing team. Your motivation is driven by a strong interest in oncological clinical trials and patient safety and by making a difference for cancer patients.
We expect a high degree of independent working, analytical reasoning and excellent communication skills in English as well as in Germain. You embrace rapidly changing requirements with an open mind, think outside the box and show a high degree of flexibility in an environment which is marked by a constant striving for excellence. You approach tasks in a structured, reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills.
We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits – e.g. JobRad, Health Programs, childcare benefits, Company summer and winter events.
*We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets.
This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.