Bicycle Therapeutics is seeking a motivated professional with oncology experience to serve as a Clinical Scientist (Associate Director) to provide scientific support for all clinical development activities involving the conduct of clinical studies. This role sits within a growing clinical department working to advance Bicycle® Toxin Conjugates as novel cancer therapeutics. The Clinical Scientist will report to the Director of Clinical Sciences within clinical development and closely interact with the medical monitor as well as with the clinical operations, data management, biostatistics, regulatory, clinical pharmacology and translational groups to facilitate execution of late phase clinical studies.This role is responsible for various aspects of clinical study design and execution including protocol writing, building study infrastructure, staff training, medical data review and analysis, investigator interactions and support of regulatory filings. Serve as a clinical science lead on the clinical study teamAuthor and review clinical documents, including protocols, amendments, informed consent forms, clinical study reports, investigator brochures, drug safety update reports, and clinical development plansLead medical data review in collaboration with the Medical Monitor, develop medical data review plan, review and query data, review codingConduct data analysis and interpretation of study resultsContribute to publication strategy and provide support for publication of dataSupport study start up, including fielding queries from IRBs, supporting responses to regulatory queries, designing CRFs and data edit checks, designing site initiation visit (SIV) training slides and presenting at SIVs as needed, etcAddress investigator questions regarding protocol and related scientific issues in coordination with the medical monitorSupport safety/pharmacovigilance activities (e.g., participation in safety signaling meetings)Develop and/or review presentation materials for Safety Review Committee/Data Safety Monitoring Board meetings; lead the data preparation for dose escalation meetings, as applicable to study stageContribute to statistical analysis plans and the design of tables, listings, and figuresContribute to clinical components of regulatory filings and documents, including INDs, briefing books, NDAs, etc.Support clinical study protocol design and development, in close collaboration with the medical monitor and protocol development teamPresent clinical study data to senior management and to external collaborators or advisorsDevelop in-depth knowledge in relevant therapeutic areas and maintain understanding of relevant competitors by attending scientific meetings and reviewing literatureCritically review and summarize literature to support document development (e.g., protocols), new indications for a given molecule, competitive intelligence and continual learningAssist in preparing materials for Investigator meetings, advisory boards, conference activities, external collaborations, and partnershipsSupport internal initiatives to develop best practices, lessons-learned, problem-solving and risk mitigation
