Early Clinical Development Leader Retinal Health

Vor 5 Tagen


Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

**THE POSITION**:
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.

This position can be filled in Ingelheim or Biberach.

**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 will be accountable 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´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 Boehringer Ingelheim´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 Therapeutic Area of Retinal Health- 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

***READY TO CONTACT US?**:
Please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330.



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