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3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of (bio-) pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.

Consultant Clinical Development – Clinical Science

For the various projects that we are running for our clients, we are looking for a consultant Clinical Development, able to provide scientific direction (ie, clinical strategy/science input) in support of clinical programs and/or studies for the development of investigational (bio)pharmaceutical compounds.

Your responsibilities include:

  • Developing the clinical development strategy of an investigational compound, including the definition of milestones and Go/No-go criteria
  • Translating biomarker data to decisive proof-of-concept studies
  • Development of clinical study designs
  • Support (interim) statistical analysis plan development
  • (Support of) interpretation of data and report writing
  • (Support) development of new endpoints
  • (Support) development of essential documents e.g., Clinical Trial Protocol, IB etc.
  • Clinical representative in Scientific Advice meetings at regulatory authorities (EMA, FDA)
  • Clinical representative in a cross functional collaborative environment
  • An equal and expert discussion partner in the communication with KOL’s
  • Coordinating of project management activities to ensure timely, uniform and quality delivery of the services provided to our clients

Requirements & qualifications

  • Relevant academic background in biomedical field, preferably PhD
  • Experience with (early) clinical drug development
  • A minimum of 5 years’ experience in the biotech or pharmaceutical industry. Experience in innovative small biotech is a prequisite.
  • Experience with developing clinical strategy, including development of (innovative) clinical trial designs and clinical development plans, preferably in a variety of clinical programs
  • Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines
  • Experience with Scientific Advice meetings at EMA or FDA is a prequisite
  • Sense of milestones, timelines & budgets
  • Excellent writing skills (English), particularly with respect to clinical protocol and reports
    Evidence of good scientific and clinical judgment, flexibility, and resilience
  • Ability to work independently and in a team environment
  • Capable of effectively managing multiple deadlines and projects
  • Ability to adapt to rapidly evolving situations and needs
  • Strong commitment to delivering high-quality work
  • Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality, and ability to put yourself in the position of our clients


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