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Senior Scientist In Vivo Biology/POC studies

Designing & operationalizing preclinical in vivo POC studies (PK/PD) of novel drug concepts.

Job

You will be responsible for a variety of different preclinical development activities including the translation of early discovery efforts into in vivo proof of concept studies according to industry-standard quality systems. You will contribute to the design of PK/PD studies, you will supervise such studies at specialist CROs, and you are responsible for data interpretation and reporting. The role also encompasses the bioanalysis of study samples, either by setting up and performing select analyses in house or outsourcing to specialty labs. In your role, you will directly report to the Chief Development Officer of Sapreme Technologies.

Profile

Tasks and Responsibilities

You deliver study designs for in vivo proof-of-concept and preclinical PK/PD studies for a variety of novel drug concepts, as mapped out together with the CDO and aligned with the company strategy.

You act as project/study manager to support the externalization of such early-stage development studies; this includes determining suitable in vivo models, selection of CROs/partners, requesting and negotiating study proposals, writing and reviewing study plans and reports.

You are the key point of contact for updates on outsourced activities to allow the team to be informed and make data driven decisions.

Your project management skills contribute to ensuring operational excellence and awareness of timelines, resource requirements for execution of the studies.

You are responsible for bioanalysis of animal tissue and blood samples according to industry standards. Your tasks also include contributing to the test article specifications and to provide formulation support.

Key requirements
You have completed an advanced degree (PhD in life sciences, preferentially pharmacology, or MSc with additional qualifications e.g., in toxicology and relevant work experience).

You have at least 2 years of working experience in the biotech/pharma/CRO or similar industry.

You must have proven ability in the design, management and interpretation of exploratory in vivo proof-of-concept studies to read out tolerability and efficacy, ideally also more advanced preclinical PK/PD studies in rodents, minimally at non-GLP level.

You are experienced in translating in vitro efficacy and toxicity data into in vivo dosing regimens for PK/PD purposes.

You have experience in setting up and qualifying bioanalytical assays including RT-QPCR, ELISA, Western blot, IHC, FACS.

You have experience with data analysis software such as GraphPad Prism; familiarity with data analysis software such as SAS or Phoenix WinNonlin is a plus.

You have experience working with antibody therapeutics, ideally ADCs, and oligonucleotides.

You have experience in a broad range of therapeutic areas (including oncology, liver and/or CNS, including rare genetic diseases).

You have excellent proficiency in English.

Knowledge of, and work experience with, regulatory guidelines for bioanalytic assays is preferred; knowledge of/work experience with preclinical PK/PD requirements toward IND submission is a plus.

You are comfortable running multiple projects in parallel.
You enjoy pro-actively proposing solutions and troubleshooting.
You are accustomed to setting-up procedures and work documentation according to industry standards.
You contribute to internal meetings and lead project meetings with collaborators/CROs.
You are accustomed to adhering to deadlines and accept an occasionally enhanced workload.
You are driven by translation of science into products.

Benefits

The job is based on a contract for 40 hour/week. Salary will be based on relevant work experience.

Location: Bilthoven, The Netherlands. Up to 20% working remotely possible.

Company profile

Sapreme Technologies is a privately-owned biotech company developing a disruptive technology platform (ENDOSCAPE®) enabling the development of superior targeted therapeutics, such as antibody-drug conjugates and oligonucleotide-based drugs.

You will join an ambitious, entrepreneurial team and develop new medicines for cancer and other indications. Projects span both the internal pipeline as well as pharma- and biotech partnered programs, allowing for external interaction.

Contact

Contact: Apply directly via careers[at]sapreme-technologies.com

Location Bilthoven
Senior Scientist In Vivo Biology/POC studies

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