Treeway is a biotechnology company with a mission to develop therapies to cure ALS. It was founded in 2012 by two ALS patients. It has established strong patient empowerment within the target market and for our lead compound we have entered clinical development phase.
As Lead Clinical Development, you will be responsible for the clinical development strategy development of clinical strategy and clinical operations of (bio)pharmaceutical compounds. You will be involved in drafting clinical development plans of clinical trials and documentation for regulatory submission.
- Responsible for the clinical development strategy of an investigational compound, including the definition of milestones and Go/NoGo criteria
- Being able to translate biomarker data to decisive proof-of-concept studies
- Responsible for the design, execution and reporting of clinical trials according to timelines and within budget
- Responsible for the writing of essential documents e.g. Clinical Trial Protocol, IB etc
- A clinical representative in Scientific Advice meetings at regulatory authorities (EMA, FDA)
- A clinical representative in a cross functional collaborative environment.
- An equal and expert discussion partner in the communication with KOL’s
- Managing external partners/service providers
- Guiding operational clinical activities
- Coordinating project management activities to ensure timely, uniform and quality delivery of the services provided to our clients
- 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;
- Evidence of good scientific and clinical judgment, flexibility, and resilience
- Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines;
- Experience with Scientific Advice meetings at EMA or FDA is a pre.
- Well-developed organizational talent
- Strong sense of meeting milestones, timelines & budgets
- Excellent communication and presentation skills
- Excellent writing skills (English)
- 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
- Strong interpersonal and communication skills to drive results in a cross functional collaborative environment.
Interested? Send your CV and short motivation letter to Treeway at firstname.lastname@example.org. For more information, you can contact Nina van Erp on +31 (0)88 783 39 29
Acquisition is not appreciated