iTeos Therapeutics is searching for a creative, resourceful, integrative thinker Clinical Scientist to translate science and strategy into executable, efficient clinical trials, review emerging clinical data and collaborate on the interpretation and reporting of study results. This position will function under the guidance and direction of the medical director. The successful candidate will be an autonomous, proactive, collaborative, experienced scientist with experience working in a clinical development environment.
- Lead the clinical study protocol/amendment development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.
- In collaboration with internal/external experts in biostatistics, clinical pharmacology, translational medicine, clinical operations and data management, execute the trial related activities.
- Establish and organize external committees such as DMC, DSMB, Steering Committees and Advisory Board.
- Collaborate on the review, analysis, and interpretation of study results and assure appropriate data review and accurate data reporting.
- Review and monitor ongoing clinical trial data related (but not limited) to safety, efficacy and PK/PD to identify study or project issues and solve them.
- Lead the development of program documents, including the clinical sections of various regulatory documents such as IND, investigators’ brochures, clinical sections of regulatory submissions, annual reports and updates and clinical study reports to support product approvals.
- Support the development of interim analysis and study report.
- Contribute to presentations and communication of study data results internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
- Conduct literature reviews as needed for study rational, and the interpretation of study data and development of next steps. Contribute to the clinical strategy, including selection of indications and combinations.
- Advanced clinical or science degree (e.g. PharmD, Advanced Practice Nursing, PhD).
- 5+ years of relevant clinical scientist experience, ideally in Oncology.
- Thorough understanding of the drug development process from pre-clinical steps through registration and post-registration required.
- Good understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
- Good understanding of GCP, ICH Guidelines and current global regulations.
- Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms.
- Resourceful, energetic, self-starter
- Approaches challenges with creativity and pragmatism
- Ability to engage team to achieve goals without direct authority
- Strong organization, documentation and communication skills.
- Excellent interpersonal skills; ability to collaborate across disciplines
- Strong ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
- Fluency in English, both written and oral.
- Based in Gosselies, Belgium. Ability to travel up to 20% of time.
For our recruitments in Belgium, we closely collaborate with a Recruitment & Selection company, PaHRtners. Your application will be automatically forwarded to them. We, together with PaHRtners, will keep all your data confidential (GDPR compliant approach ).