Scientific Strategy & InnovationParticipate in strategy, design, authoring, and review of clinical documents, including protocols, amendments, informed consent forms, clinical study reports, investigator brochures, drug safety update reports, and clinical development plansYou will provide scientific input into the design of clinical protocols, amendments, and related documents.You will stay current with the scientific literature and competitive landscape in order to contribute to clinical development strategy.Perform literature searches and critically review and summarize results to support activities such as document development, new indications for a given molecule, and competitive intelligenceYou will develop innovative solutions to cross-functional challenges.Project Delivery & ExecutionContribute to clinical study design and conduct for development of novel tumor antigen-targeted Bicycle® therapeuticsLead medical and safety data review and associated meetings in collaboration with the Medical Monitor, review and query dataParticipate in study start up, including identification of investigators/sites, feasibility, review of CRF, etcDevelop content and give presentations during site initiation visits; participate in site trainingSupport internal initiatives to develop best practices, lessons-learned, problem-solving, and risk mitigationYou will lead complex clinical science activities for assigned studies, serving as the primary scientific point of contact to ensure program goals are successfully met.You will oversee and analyze clinical trial data on an ongoing basis, identifying and contributing to interpretation of trends to support clinical decisions and study conduct.You will ensure alignment with organisational priorities by collaborating with Clinical Operations to ensure timely and high-quality study execution in line with the clinical development plan.Data, Documentation & ComplianceYou will author and review key clinical and regulatory documents, including protocols, Investigator's Brochures (IBs), clinical study reports (CSRs), and sections of regulatory filings (e.g., INDs, NDAs).Contribute to regulatory documents, including INDs and briefing books and other regulatory documentsContribute to publication strategy and provide support for publication of dataYou will ensure data integrity and compliance by participating in the development of case report forms (CRFs), data review plans, and statistical analysis plans.You will present scientific data to internal governance bodies, project teamCollaboration & Stakeholder ManagementServe as a liaison between study team, CROs, and investigatorsAssist in preparing material for advisory boards, conference activities, external collaborations, and partnershipsPotential to mentor other clinical scientistsAttend congresses as needed to support publications as well as interactions with key opinion leaders and investigatorsYou will act as a core partner to Medical Monitors, Clinical Operations, Biostatistics, Translational and Regulatory Affairs, ensuring seamless cross-functional execution.You will build strong relationships with clinical investigators and key opinion leaders, acting as a key scientific representative for Bicycle.
