Research and Development has been the foundation of Boehringer Ingelheim's success and continues to be the major driver of innovative new medicines for the treatment of diseases with an unmet medical need. The Boehringer Ingelheim R&D organisation has a successful track record of building up a remarkable development pipeline, thereby bringing several important drugs to the market, including meloxicam (Mobic®), telmisartan (Micardis®), nevirapine (Viramune®), pramipexole (Sifrol®), tiotropium (Spiriva®), dabigatran (Pradaxa®), empagliflozin (Jardiance®), afatinib (Giotrif®), nintedanib (Ofev®) and linagliptin (Trajenta®). These products have helped millions of patients and secured growth for the company that is significantly above the industry average.
The Boehringer Ingelheim R&D organisation is committed to further increasing its access to breakthrough science, fueled by external innovation, and to translate these unprecedented scientific discoveries into novel therapies.
Background
Boehringer Ingelheim's early clinical development function is comprised of ~70 people working in teams in Germany (Biberach an der Riß and Ingelheim) and the US (Ridgefield, CT) with a focus on early clinical development, first-in-man (FIM) studies, Proof of Clinical Principle (PoCP) trials and Clinical Pharmacology studies.
Over the past year, the function has been undergoing a process of positive transformation and growth. The vision for this function is to create a Centre of Excellence in early clinical development by aligning strategic and operational execution excellence between all functions involved at this early stage of drug development including research, human pharmacology, biomarker, preclinical toxicology and drug and device groups.
The Position
Are you looking for a challenging job that will allow you to apply and further develop the knowledge and skills in early clinical development you have acquired during your career?
Then we welcome you to assume a wide range of tempting tasks as a Clinical Trial Leader - Early Clinical Trials. As part of the Early Clinical Integration Team, a cross-functional group of experts from line functions involved in early clinical trials, the role will be responsible for the strategic and operational execution excellence of programs from start of development (SoD) to proof of clinical principle (PoCP). The successful candidate will help to integrate information from preclinical safety, basic research findings, candidate biomarkers, the unmet medical need in patients as well as operational and regulatory aspects into a competitive development strategy.
Tasks & responsibilities
* As a Clinical Trial Leader - Early Clinical Trials (ECT), you will lead a trial team and support Early Clinical Integration (ECI) project teams to provide strategic and clinical operational guidance and to drive feasibility of clinical trial protocols.
* You are accountable in the context of a cross-functional team for the design, planning, conduct and reporting of mono- and multi-center clinical trials leading to the Proof of Clinical Principle (PoCP) milestone of Boehringer Ingelheim (BI)'s new development pipeline compounds as well as Clinical Pharmacology studies (e.g. hADME and DDI trials).
* With your expertise you will maintain oversight, ensure feasibility of trial plans and proactively assess and mitigate risks.
* Furthermore, you will role-model BI's company culture and target behaviors in trial teams and cross-functional teams.
* In your role you will communicate the trial status to stakeholders/senior management on a regular basis, escalating issues as appropriate.
Requirements
* Applicants are MDs or PhDs (MD PhD or MD with a science background preferred)
* Pharmaceutical industry experience in the Therapeutic Area of Cardiometabolic diseases (e.g. obesity, MASH)
* Strong background in Early Clinical Development / Clinical Pharmacology, especially in early clinical trials of Proof of Mechanism / Proof of (clinical) Principle or Concept is desirable
* Understanding of major regulations (US FDA, EMA and PMDA) as well as familiarity with guidelines and standard of care is mandatory
* Strong and in-depth understanding of teamwork and high-performance teams
* Working in a multi-cultural environment and in-depth understanding of corporate culture and cross-culture dynamics
* Fluency in written and spoken English is a must
* Ability to fulfill your tasks and responsibilities partially remotely
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:
Recruitment process:
Step 1: Online application - application deadline is 13th February, 2025
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 Mitarbeiter*innen, Patienten*innen und Communitys profitieren.
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