Search the 11 jobs at Bicycle Therapeutics

The Trial Master File (TMF) Specialist will manage and oversee TMF operations, ensuring eTMFs are inspection ready. Responsibilities include process improvement for clinical documents, reviewing TMF plans, performing quality checks, overseeing QC reviews, and participating in study team meetings. The role emphasizes compliance with regulatory standards and contributing to metrics and KPIs for inspection readiness.

The Biomarker Operations Senior Associate will coordinate biomarker operations activities, manage laboratory setup, oversee sample management, and collaborate with Translational Sciences and Clinical Operations teams to support clinical trials. They will ensure proper data transfer and reconciliation of biomarker data and establish processes for consistency across trials.

The Head of Compliance & Ethics will strategize and lead the compliance and ethics program, ensuring adherence to legal and ethical standards across corporate activities, particularly in clinical development and commercial operations. This role involves embedding compliance principles in company operations, conducting risk assessments, leading training programs, and managing compliance investigations.

The Associate Director of Biostatistics will lead the biostatistical activities in clinical studies at Bicycle Therapeutics, overseeing biostatistical deliverables, providing statistical expertise, and ensuring high-quality collaboration with vendors and internal teams. This role involves supporting protocol development, conducting statistical analysis, and managing biostatistical documentation.

The Procurement Manager at Bicycle Therapeutics will lead the supplier management process for CMC functions, focusing on routine reviews, escalation meetings, and improvement of RFI/RFP processes. They will evaluate supplier quality and compliance, oversee meeting schedules, generate reports, and liaise with cross-functional teams.

The Senior Director of Isotope Supply is responsible for leading the establishment of a global isotope supply chain for Bicycle Therapeutics. Key responsibilities include vendor selection, optimization for clinical manufacture, scale-up and validation of commercial supply, and ensuring quality and regulatory compliance in isotope supply for radiopharmaceutical medicines.

The Director of Drug Safety leads clinical safety and pharmacovigilance support for assigned compounds, managing risk management activities and ensuring compliance with global regulations. This role entails developing a thorough understanding of the safety profile of products and collaborating with cross-functional teams to evaluate safety data and implement strategies for patient safety and regulatory compliance.

The Associate Director of DMPK will design and execute non-clinical studies in support of drug development projects, collaborating with medicinal chemists and pharmacologists. Responsibilities include creating DMPK strategies, conducting experiments, interpreting data, and managing budgets with CROs while integrating data to inform on pharmacokinetic/pharmacodynamic relationships.

The Legal Counsel will draft, review, and negotiate legal agreements, provide legal support for clinical trials, assist with contract approvals, supervise external counsel, and manage any litigation while interacting with stakeholders across the UK and US.

The Research Scientist will support therapeutic research projects by designing and conducting binding characterization experiments, mainly utilizing Surface Plasmon Resonance (SPR) techniques. Responsibilities include data analysis, enhancing lab capabilities, and collaborating with team members to inform project design. This role involves both core and exploratory work in a dynamic lab setting.

As the Information and Cyber Security Manager, you will manage the Information Security Management System according to ISO 27001:2022, lead ISO certification activities, assess information security risks, develop IT and IS policies, manage security training, and ensure compliance with data protection regulations across the organization.