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
Please attach your CV to our contact form!