Scientist - Pharmacometrics

Vor 5 Tagen

Munich, Deutschland Boehringer Ingelheim Vollzeit

**Scientist - Pharmacometrics**
**-**
**232695**

**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 POSITION**

The positions can either be filled in Biberach or Ingelheim.
This job is posted permanently as we have a continuous demand for this profile.

**The Pharmacometrics Group**

We strive to implement model-informed drug development (MIDD) in projects as well as across projects and disease areas in order to optimize study designs and to inform drug development strategies, decision-making and successful approval. Our aim is to foster the quantitative understanding of diseases and pharmacological interventions in close collaboration with other disciplines.

We believe that every member of the PMx group should be empowered to shape the future of PMx at Boehringer Ingelheim by actively contributing or leading internal and external working groups focusing on e.g. PBPK, disease strategies, innovative methods, IT, standardization and processes.

Within our group we value active contributions to discussions, a culture of sharing knowledge, active feedback and a positive “how to” attitude in challenging situations.

**Pharmacometrician (all levels)**

As a pharmacometrician with BI you actively contribute to early and late phase clinical drug development working closely together with experts in the fields of research, medicine, clinical pharmacology, biomarker, clinical development, and statistics.

You are assigned to drug development projects approximately two years before first-in-man clinical trials and support projects until successful regulatory approval and beyond.

**Tasks and responsibilities**

**Pharmacometrician**

With the support of your supervisor you will- develop the PMx strategy and contribute to the clinical development plan for clinical development projects and identify opportunities where model-informed drug development (MIDD) can advance the understanding of pharmacological activity, efficacy and safety.-
- be responsible for the planning and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta-analysis as well as PBPK to support internal decision making and successful approval.-
- ensure the timely delivery of PMx documents (e.g., dataset specification, analysis plans, and reports) and documents where PMx is co-author (e.g., clinical development plan, pediatric investigational plan, submission documents).-
- organize and manage projects with external organizations such as academic institutions or CROs.-
- represent PMx in internal initiatives and working groups collaborating closely with other disciplines.**Additional tasks as Senior Pharmacometrician**

As a senior pharmacometrician, you perform the responsibilities of the pharmacometrician independently and, additionally, you- contribute to internal/external initiatives.-
- are responsible to continuously evaluate and implement novel PMx methods and approaches and may provide support and/or development of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes-
- represent PMx in internal and external initiatives/working groups such as process harmonization, IMI calls, ISoP groups, OSP-
- You will have the opportunity to act as a “CPPI” (Clinical Pharmacology and Pharmacometrics Integrator) where you, in close alignment with clinical pharmacology experts, will be accountable for-
- representing PMx and clinical pharmacology aspects (e.g. drug-drug interactions, formulation development, food effect, absolute bioavailability) in early and late stage clinical drug development teams and authority interactions-
- author PMx and clinical pharmacology contributions to documents such as the clinical development plan, investigators brochure, pediatric development plans-
- the conduct of analysis regarding clinical pharmacology aspects on a trial and project level**Additional tasks as Principal Pharmacometrician**

As a Principal Pharmacometrician, you perform the responsibilities of a senior pharmacometrician and, additionally, you- act as an internally and externally recognized Pharmacometrician and have the opportunity to act as the leader of Early Clinical Development Teams and Clinical Pharmacology and Biomarker Teams (“ECD integrator” / “CPBM integrator”) representing Translational Medicine and Clinical Pharmacology in core teams and decision body meetings.-
- continuously an

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