3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg, Oss & Amsterdam. We are dedicated to the development of (bio-) pharmaceuticals such as small molecules, vaccines and ATMP’s. 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 innovative biotech companies, start-ups, academia, and pharma companies.

Consultant Clinical Development – Clinical Sciences

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 may include:

• Co-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 end-points
• (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
• Coordinating of project management activities to ensure timely, uniform and high-quality deliverables of the services provided to our client

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 prerequisite.
• Experience with (co-)developing clinical strategy, including development of (innovative) clinical trial designs and clinical development plans
• Sense of milestones, timelines and budgets
• Ability to adapt to rapidly evolving situations and needs
• Capable of effectively managing multiple deadlines and projects
• Experience with Scientific Advice meetings at EMA or FDA is a prerequisite
• Evidence of good scientific and clinical judgment, flexibility, and resilience
• Ability to work independently and in a team environment
• Excellent writing skills (English), particularly with respect to clinical protocols and reports
• Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines
• Strong commitment to deliver high-quality work
• Essential personal skills: pro-active, team player, entrepreneurial, can-do mentality, and ability to put yourself in the position of our client

Interested?

Contact Us

Please attach your CV and short motivation letter in our contact form!

Acquisition is not appreciated!