![Boehringer Ingelheim](https://media.trabajo.org/img/noimg.jpg)
Clinical Trial Leader
vor 4 Wochen
**Clinical Trial Leader**
**-**
**233667**
**Our Company**
At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family-owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.
The business aim of Boehringer Ingelheim is to continue to drive forward with the innovative development of its existing product portfolio through organic growth, in cooperation with its external partners. To do this, Boehringer Ingelheim operates a global research network with major facilities in Biberach, Hannover and Ingelheim (Germany), Ridgefield and St. Joseph (USA), and in Vienna (Austria), supported by smaller facilities in Ochsenhausen (Germany), Kobe (Japan), Innsbruck (Austria), and Geneva (Switzerland).
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**
**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**:
- PhD. or MD with pharmaceutical industry experience in the Area Therapeutic Area of Rheumatology or Gastroenterology is preferred-
- 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**Recruitment process**:
Step 2: Virtual meeting in the period from until mid of May 2023
Step 3: On-site interviews in the period until end of May 2023
**WHY BOEHRINGER INGELHEIM?**
- This is where you can grow, collaborate, innovate and improve lives._
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovat
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