DMPK Outsourcing scientist

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A major Biopharmaceutical company is searching for a; DMPK Outsourcing scientist

As a DMPK Outsourcing scientist you are responsible for ensuring that the external DMPK studies required to support the drug discovery and development projects are timely performed according to the quality standards and study design communicated by the client. You also play a key role in advising the project on ethical aspects, selection of the CRO and study design, particularly for in vivo studies.
Job Scope
Your core role will be to provide the projects with access to fit-for-purpose external support to answer various types of DMPK-oriented questions for different treatment modalities (NCEs, NBEs and gene therapy). The main focus will be on in vivo support, but depending on your experience you may also get involved in in vitro studies. You will act as the single point of contact between the CRO and the study requester/DMPK rep, and are responsible for liaising with all key contributors to the study (eg logistics, formulation and subject matter experts) in order to facilitate the execution. You are also accountable for keeping the study requester timely informed in case of any unforeseen delays or events and playing an active role in addressing/escalating any issues related to the quality of the external DMPK studies at the CROs.
Job Accountabilities
* Organize, coordinate and monitor external in vivo (and in vitro) DMPK studies at our preferred CROs
* Ensure study or assay protocols are reviewed and approved by relevant subject matter experts (eg DMPK rep, ADME, TB&B)
* Review data and/or full reports, highlight any issues to the CRO and/or internal experts, report the data to the study requester and, if applicable, upload data onto the database
* Monitor the performance of the CROs, track recurrent issues and act as a first line of response for day-to-day problem solving
* Actively contribute to DMPK outsourcing updates and other internal meetings for key stake holders, and to meetings with CROs
* Evaluate CROs and identify solutions for (recurring) problems
* Closely collaborate with the Document Management and Contracts & Partnerships teams where appropriate
* Check invoices and monitor opportunities to reduce outsourcing costs
* Continuously look for process improvement opportunities and new CROs/techniques of interest
Technical Capabilities
- Broad understanding of drug discovery and development ideally including NBEs and gene therapy
- General knowledge of in vivo DMPK
- Basic bioanalytical knowledge
- Proficiency in English
- Team player with strong communication skills
- Good organizational skills
Primary Qualifications (Minimum Requirements)
PhD and/or degree in pharmaceutical sciences, biomedical sciences or related discipline with 3-5 years hands-on experience in outsourcing

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start date
12 months
Michael Bailey Associates
Published at
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