Senior Clinical Scientist - Watertown, MA (US) or Gosselies (BELGIUM)

ROLE :

Senior Clinical Scientist

iTeos Therapeutics is searching for a creative, resourceful, integrative thinker Senior / Clinical Scientist to support the translation of 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 report to the Clinical Development Lead and will function under the guidance of the Lead Clinical Development Scientist.

The successful candidate will be an autonomous, proactive, collaborative, experienced scientist with experience working in a clinical development environment.

MAIN RESPONSIBILITIES

• Support the senior clinical development staff on study protocols and amendments collaborating cross-functionally to translate 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 plans to execute one or more trials including CRF design, laboratory manual review, data review plan and the statistical analysis plan.
• Author / review clinical contributions to clinical study reports (CSRs) and clinical portions of Clinical and Regulatory Documents (e.

g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.).

• Develop site and CRA training materials and present these at PSVs / SIVs and external meetings.
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management / Programming.
• Collaborate cross-functionally to monitor clinical data for specific trends.
• Participate in the preparation of regular program-level safety review meetings.
• Assist with the organization of external committees such as DMC, DSMB, Steering Committees and Advisory Board.
• Develop a relationship with study investigators and with relevant clinical experts.
• Conduct literature reviews as needed for study rationale, and the interpretation of study data and development of next steps.
• Ensure appropriate clinical documents and correspondence are shared cross-functionally and submit to TMF.

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

• Bachelor’s degree in a related field required; master’s degree preferred (e.g. pharmacy, Advanced Practice Nursing).
• 3+ 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.

LEADERSHIP CHARACTERISTICS

• Resourceful, collaborative, detail oriented.
• Approaches challenges with creativity and pragmatism. Ability to work in a fast-moving and challenging biotech environment.
• Ability to engage teams to achieve goals without direct authority.
• Driven to move the R&D programs forward at full speed while maintaining quality.

OFFER

• A stimulating 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 environment where you are empowered to apply and develop your knowledge and skills as part of a talented and highly engaged global team.
• An attractive compensation and benefits package in line with the position responsibilities and your experience.
30+ days ago