Senior Principal Scientist

vor 2 Wochen


Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

**THE POSITION**:
You will also have the exciting prospect of acting as a Data Science Lead (DSL) in clinical development project teams to fulfill our vision of turning data into knowledge. As DSL, you’ll have the chance to shape and contribute to projects already prior to first-in-man clinical trials.

**Tasks & responsibilities**:
- As a Senior Principal Scientist in Pharmacometrics, you will develop the pharmacometric strategy and identify opportunities where pharmacometrics and other advanced data analytic approaches can further the understanding of pharmacological activity, efficacy and safety of a drug.-
- advising clinical development teams on opportunities and limitations of Data Science approaches (e.g. pharmacometrics, computational biology, systems pharmacology, descriptive analytics)-
- developing and aligning the TMCP data and data analysis strategy in close alignment with other DS experts within our department-
- complex clinical development projects up to submission representing pharmacometrics at important regulatory meetings such as advisory boards-
- Furthermore, you will be responsible for the planning and execution of relevant pharmacometric analyses to support internal decision making, disease understanding and successful approval.- You will ensure the timely delivery of analysis-related documentation (e.g., dataset specification, analysis plans, and reports) and documents where you are co-author (e.g., clinical development plans).- Moreover, you will continuously evaluate or develop, implement, and promote innovative pharmacometric methodologies, approaches, (software) tools and related business processes.- You will provide consultancy and expert advice for other scientists and stakeholders across therapeutic areas as an internally and externally recognized scientist.- You will lead and/or contribute to internal and external initiatives/working groups (e.g. focus groups in your therapeutic area of expertise, across department initiatives, process harmonization, IMI calls, ISoP groups, Open Systems Pharmacology), organize and manage projects with external organizations and establish and maintain contacts to key opinion leaders in the field of pharmacometrics and data science in general.

**Requirements**:
We expect a strong team player, who is able to successfully act in a global and remote context. Good interpersonal skills with the ability to effectively interact internally as well as externally and the ability to pro-actively identify issues and provide solutions are a pre-requisite.- PhD. or master’s degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or relevant area of focus- Long-standing experience in Pharmacometrics/Data Science in the pharmaceutical industry, regulatory agencies, CRO or academia with relevant experience in working in clinical development teams-
- In-depth knowledge in other data science fields, clinical pharmacology, clinical drug development, MID3, and regulatory guidelines

Fixed term contract: no

Part time eligible: yes

Organizational unit: CBD Innovation/ Global TMCP/ TMCP Data Sciences/ Pharmacometrics

Internal job offers are generally addressed to employees working in their current position for at least one year or working on a fixed term contract ending within one year.

**For employees with a current contract of limited duration, legal / labor agreement requirements for contract extension will be considered.**

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

Recruiter : Marco Kolk

Hiring Manager: Valerie Nock



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