The Position Are you a strategic thinker with a medical background, ready to create new concepts in early clinical development to enhance our department's competitiveness? Boehringer Ingelheim is looking for a dynamic and innovative individual to provide expert advice to employees within and outside the department on early clinical project development in the therapeutic area of Inflammation. In this role, you'll lead the development of new early clinical development concepts and strategies, manage the planning and execution of clinical trials, and potentially supervise and mentor team members. If you're ready to take on this challenging and impactful role, we would love to hear from you. Tasks & responsibilities As an expert in early clinical development, you'll be at the forefront of creating innovative concepts. By leading workstreams or strategic initiatives, you'll be instrumental in shaping the future of drug development and enhancing our competitive edge. Key focus areas include developing a study design that answers the relevant questions of the clinical trial and optimally uses existing resources. Your medical expertise will be invaluable in guiding colleagues throughout the organization. Taking charge of specialist areas like the EKG working group, you'll be passing on knowledge and fostering a culture of shared learning. You'll also be responsible for the medical evaluation of the clinical projects, including the assessment of adverse events/side effects (including SAEs and SUSARs). Your strategic insights will be crucial in our international project teams. As a member of the Early Clinical Integration (ECI) team or Clinical Pharmacology Biomarker Deliverable Team (CPBM DT), you'll be shaping the future of our HPBU/CD&O working model. A key part of your role will be to ensure the proper regulatory submission/approval by compiling and writing the necessary documents such as the trial plan (CTP), participant information/informed consent, trial forms (CRF), Integrated Risk Management Plan (IQRMP, etc.). You'll also be tasked with monitoring (safety, quality, budget, time specifications) and reporting the trial. As a Clinical Trial Leader (CTL), you'll be responsible for overseeing internal and external clinical trials. Your focus will be on leading the Core Trial Team (Trial Data Manager, Trial Statistician, Trial Pharmacokineticist, etc.) and Clinical Trial Manager (CTM), as well as maintaining an overview of project- and study-specific vendor services. Stepping into the role of a Clinical Trial Manager (CTM), you'll manage internal and external clinical trials in Germany. Collaborating with ECT-internal and external functions, you'll ensure the smooth execution of all relevant activities/processes in the planning, preparation, execution, reporting, and documentation of clinical trials. Key aspects of your role will include local trial monitoring (safety, quality, budget, time specifications) and trial site management, including selection, guidance/training, initiation, and on-site monitoring. Requirements Completed medical studies with profound clinical-pharmacological or clinical-experimental knowledge and experience, with a proven track record in the field of Clinical Pharmacology or clinical research in the area of Inflammation Deep understanding of GCP-compliant execution of clinical trials, ideally also in investigator or investigator doctor function, demonstrating a meticulous, structured, effective, and efficient working method Broad knowledge and experience in early clinical development and the implementation of Proof of Clinical Principle (PoCP) studies, with the ability to independently and promptly identify problems and define solution paths Familiarity with relevant international and national regulations such as the Declaration of Helsinki, GCP, AMG, MPG, GCP-V, relevant guidelines (ICH, FDA, EMA), and the ability to present complex relationships to larger groups Ability to lead teams and foster a collegial and needs-based communication and collaboration, coupled with an organized and quality-conscious work ethic to successfully manage projects according to given conditions Fluent in English, both spoken and written, supplemented by proficiency in electronic applications, particularly MS Office (Outlook, Word, Excel, and PowerPoint) Ready to contact us? If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: 49 (0) 6132 77-3330 or via mail: hr.deboehringer-ingelheim.com Recruitment process: Step 1: Online application - The job posting is presumably online until 18th February, 2025. We reserve the right to take the posting offline beforehand. Applications up to 5th February, 2025 are guaranteed to be considered. Step 2: Virtual meeting starting mid of February Step 3: On-site interviews starting end of February Unser Unternehmen Bei Boehringer Ingelheim entwickeln wir bahnbrechende Therapien, die das Leben von Mensch und Tier verbessern. Als 1885 gegründetes und seitdem im Familienbesitz befindliches Unternehmen nehmen wir eine langfristige Perspektive ein. Mit 52.000 Mitarbeitenden weltweit setzen wir unsere Ziele um und fördern dabei eine vielfältige, gemeinschaftliche und inklusive Unternehmenskultur. Wir sind überzeugt: Mit talentierten und ambitionierten Mitarbeitenden und ihrer Leidenschaft für Innovationen heben wir die Grenzen des Erreichbaren immer wieder auf. Warum Boehringer Ingelheim? Bei uns können Sie wachsen, zusammenarbeiten, innovativ sein und Leben verbessern. Wir bieten Ihnen herausfordernde Tätigkeiten in einem respektvollen und kollegialen globalen Arbeitsumfeld mit einer Vielzahl von auf Innovation ausgerichteten Denkweisen und Methoden. Darüber hinaus sind für uns Qualifizierung und Entwicklung für alle Mitarbeitenden von zentraler Bedeutung, denn Ihr Wachstum ist unser Wachstum. Boehringer Ingelheim ist ein globaler Arbeitgeber, der sich für Chancengleichheit einsetzt, und ist stolz auf seine vielfältige und inklusive Kultur. Wir begrüßen die Vielfalt von Perspektiven und streben nach einem inklusiven Umfeld, wovon unsere Mitarbeiterinnen, Patienteninnen und Communitys profitieren. Sie möchten mehr erfahren? Dann lesen Sie hier weiter https://www.boehringer-ingelheim.com