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.
- Contribute to the clinical strategy, including selection of indications and combinations
- 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, contribute to the development of the plan to execute trial design including CRF design, laboratory manual review, data review plan, statistical analysis plan review and finalization.
- Collaborate on the review, analysis, and interpretation of study results and assure appropriate data review and accurate data reporting.
- Identify study issues and program issues by reviewing and monitoring emerging clinical data related to safety, efficacy and PK/PD.
- Develop sound, strategic solutions to issues and collaborate with the clinical study team to ensure issue resolution.
- Conduct literature reviews as needed for study rational, and the interpretation of study data and development of next steps.
- Work closely with the medical monitor to ensure he/she is informed of pertinent study information, including but not limited to safety and efficacy data.
- Support 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.
- Work closely with the translational medicine team to support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules, and potential stratification biomarkers.
- Assist with the development of presentations to communicate study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
- Serve as clinical science representative on cross-function teams as assigned.
- Advanced clinical or science degree (e.g. PharmD, Advanced Practice Nursing, PhD).
- 5+ years of clinical, technical/operational experience in planning, executing, reporting and publishing clinical studies within the pharmaceutical industry and/or at clinical sites.
- Demonstrated ability to review and summarize study data, including experience in preparing and presenting data.
- Fluency in English, both written and oral.
- Thorough understanding of the drug development process from pre-clinical steps through registration and post-registration required.
- Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, translational medicine, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).
- Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy.
- Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
- Successful track record for the ability to interpret, analyze, and present clinical data, including aggregate data analyses, in order to inform decision-making and set clinical strategy.
- Hands-on experience performing systematic literature search, summarizing the search results and presenting the conclusions to wide spectrum of audiences.
- 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.
- Strong organization, documentation and communication skills with an ability to multitask.
- Excellent interpersonal skills; ability to collaborate across disciplines.
- Detailed knowledge of GCP, ICH Guidelines and current EU EMEA and US FDA regulations.
- Based in Gosselies, Belgium. Ability to travel up to 10% of time.
- Resourceful, energetic, self-starter
- Approaches challenges with creativity and pragmatism
- Ability to engage team to achieve goals without direct authority
- A stimulating scientific position within a high-potential innovative biotech company.
- The opportunity to work in a science-driven, dynamic, human‐sized, respectful and professional environment.
- A challenging scientific and business growth in which you get to bring your knowledge and skills.
- A permanent contract and an attractive salary package in line with the position responsibilities and your experience.