Consultant Clinical Development – Clinical Science – 3D-PharmXchange
3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of 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.
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.
- 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 the 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 pre.
- Experience with developing clinical strategy, including the 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 pre.
- 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
For more information about this vacancy, contact Managing Partner Albert Peters +31 6 28209882