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(Senior) Consultant non-clinical development (ADME)

Company profile

3D-PharmXchange is a drug development consultancy company located in Tilburg, Oss and Amsterdam. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem solving and long-lasting relationships. Our team of experts cover the key areas in drug development of non clinical, clinical, CMC, QA and regulatory affairs. In addition, we provide project leadership and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups and academia. Our mission is to provide true patient-centered smart expert guidance to support the development of safe and efficacious drugs at the highest quality, highest efficiency and lowest costs.

The role

For the diverse drug development projects we deliver for our clients, we are seeking a (Senior) Consultant Non-Clinical Development to join our growing team. You will contribute to non-clinical development programs across multiple therapeutic areas, with a strong focus on ADME and experience in toxicology and/or safety pharmacology. Working closely with clients, CROs, and multidisciplinary teams, you will provide scientific oversight, interpret data, and support strategic decision-making in a dynamic consultancy environment.

Key tasks and responsibilities

  • Plan, coordinate, monitor, and interpret ADME and drug metabolism studies in collaboration with clients, CROs, and internal project teams.
  • Design, oversee, and evaluate non-clinical safety studies, including toxicology and safety pharmacology studies performed by CROs.
  • Review and present non-clinical study data and translate findings into clear conclusions and recommendations for development teams.
  • Support non-clinical development strategies in line with global regulatory requirements for chemical entities and/or biological medicinal products.
  • Contribute to translational development discussions by connecting non-clinical findings with clinical development considerations where relevant.
  • Prepare, review, and summarize biocompatibility assessments, safety assessments, literature searches, and information from non-clinical databases.
  • Draft and review regulatory and development documents, such as investigators’ brochures, briefing documents, and non-clinical sections of eCTD submissions.
  • Ensure that relevant non-clinical activities are conducted in accordance with Good Laboratory Practice and applicable quality standards.
  • Participate in project teams, coordinate project activities, and contribute to effective communication with clients, CROs, and other stakeholders.

Requirements

  • PhD or MSc degree in Life Sciences, with experience in drug development or similar field
  • At least 3 years of experience as a study director, non-clinical project manager or other relevant drug development role
  • Communication skills: good oral, writing and presentation skills
  • Personality skills: pro-active, team player, results-oriented, can-do mentality and ability to put yourself in the position of our clients
  • Experience in ADME, including conducting and/or monitoring drug metabolism studies
  • Experience in designing, monitoring or conducting safety (toxicology) studies at CRO’s and analyzing/presenting data
  • Knowledge of and experience in global regulatory requirements for the development and registration of new medicinal products (chemical entities and/or biologicals)• Affinity with or knowledge of translational science is considered an advantage
  • Experience in drafting and reviewing biocompatibility and/or safety assessments, researching literature and non-clinical database resources, and summarizing information
  • Experience in writing and/or reviewing documents for specific global regulatory purposes, e.g. investigators’ brochures, briefing document, (non-)clinical dossier (eCTD), etc.
  • Understanding of Good Laboratory Practice (GLP) regulations
  • Project coordination and project team participation

Our offer

  • A challenging and varied role within a growing life sciences consultancy
  • Opportunities to broaden and deepen expertise through working with a wide range of clients, projects, therapeutic areas and modalities across different stages of drug development
  • Support for continuous education through training, conferences, and development aligned with your career ambitions
  • A collaborative, multidisciplinary team with strong scientific and regulatory expertise
  • A high degree of autonomy, responsibility, and ownership in your work
  • Competitive employment conditions, tailored to your experience and role
  • Flexibility to adapt to different project environments and a healthy work–life balance
  • Work alongside with a team of friendly and supportive colleagues!

Interested?

Send your CV and short motivation letter to hr@3d-pxc.com.

Acquisition is not appreciated!