(Senior) Manager Clinical Safety*

(Senior) Manager Clinical Safety

(Senior) Manager Clinical Safety

Apply locations Tuebingen (Germany), Munich

time type: Full time

posted on: Posted 6 Days Ago

job requisition id: JR100360

Overview

We are currently seeking a full-time (Senior) Manager Clinical Safety 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 regulatory filings of clinical trials in various oncological indications.

You will be an active 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 mission

Your main responsibilities will include but are not limited to the following tasks:

1. Establish and maintain functional plans in the area of PV and MM in-house and together with external service providers.
2. Organize and contribute to safety (review) meetings (internal and external), present relevant safety data, and compile meeting minutes.
3. Review safety sections of trial-related documents (CTP, IB, ICF, CSR etc).
4. 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.
5. Ensure that safety relevant data from clinical and safety databases are allowing safety assessment by MM, as applicable.
6. Analyze safety-related data in the eCRF or listings extracted from databases to identify relevant safety events and to support data reconciliation.
7. Contribute to the development, maintenance and implementation of controlled documents like SOPs and other process documents for clinical trials.
8. Ensure processes for PV and Safety Reporting are implemented and executed consistently throughout clinical studies.
9. Support trainings on safety-related processes e.g. during Investigator Meetings as well as site initiation visits, for in-house teams as well as contract research organizations.

Your profile

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 and preferably also in German. 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.

Why us?

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., job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.

Notice

*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.

Welcome!

About Us

Immatics’ fundamental purpose is to apply its technology and drug development efforts toward improving the outcomes for cancer patients through the exciting advances of using the immune system to fight the disease.

From its research and development origins in Tübingen, Germany, to its cell therapy center in Houston, Texas and corporate functions in Munich, Germany, Immatics represents a trans-Atlantic team united to build a global leader in T cell receptor-based immunotherapies.

We are only accepting digital applications via the application form of each position. For general inquiries on recruiting topics, please write a message to for German recruiting topics or for US recruiting topics.

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