Senior Consultant Non-Clinical Development (ADME) at 3D-PharmXchange

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Senior Consultant Non-Clinical Development (ADME)

3D-PharmXchange

Tilburg, North Brabant, Netherlands

Hybrid

Expert

posted 96 days ago

View company profile

Vacancy Summary

Join 3D-PharmXchange as a Senior Consultant in Non-Clinical Development, focusing on ADME. You'll lead diverse drug development projects, ensuring scientific oversight and strategic decision-making in a dynamic consultancy environment.

Required skills

Databases

English level

Professional

3D-PharmXchange is a drug development consultancy located in Tilburg, Oss, and Amsterdam, dedicated to providing strategic and operational support to clients in the pharmaceutical and biotech sectors. Our mission is to deliver patient-centered expert guidance for the development of safe and effective drugs.

The Role

We are looking for a Senior Consultant in Non-Clinical Development to join our expanding team. You will play a crucial role in non-clinical development programs across various therapeutic areas, emphasizing ADME, with experience in toxicology and/or safety pharmacology.

Responsibilities

•

Plan, coordinate, monitor, and interpret ADME and drug metabolism studies in collaboration with clients, CROs, and internal teams.

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Design, oversee, and evaluate non-clinical safety studies, including toxicology and safety pharmacology studies conducted by CROs.

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Review and present non-clinical study data, translating findings into clear conclusions and recommendations for development teams.

•

Support non-clinical development strategies in compliance with global regulatory requirements for chemical entities and biological medicinal products.

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Contribute to translational development discussions by linking non-clinical findings with clinical development considerations.

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Prepare, review, and summarize biocompatibility assessments, safety assessments, literature searches, and information from non-clinical databases.

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Draft and review regulatory and development documents, including investigators’ brochures and non-clinical sections of eCTD submissions.

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Ensure that non-clinical activities adhere to Good Laboratory Practice and applicable quality standards.

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Participate in project teams, coordinate project activities, and maintain effective communication with clients, CROs, and stakeholders.

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