Associate Director, Clinical Scientist

Company Description

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Massachusetts US. 

Culture is key and all Bicycle employees actively embrace and role model our company values: 

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.   
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination. 
• We are One Team. We only succeed when we work together.  

Job Description

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 team
• Author and review clinical documents, including protocols, amendments, informed consent forms, clinical study reports, investigator brochures, drug safety update reports, and clinical development plans
• Lead medical data review in collaboration with the Medical Monitor, develop medical data review plan, review and query data, review coding
• Conduct data analysis and interpretation of study results
• Contribute to publication strategy and provide support for publication of data
• Support 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, etc
• Address investigator questions regarding protocol and related scientific issues in coordination with the medical monitor
• Support 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 stage
• Contribute to statistical analysis plans and the design of tables, listings, and figures
• Contribute 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 team
• Present clinical study data to senior management and to external collaborators or advisors
• Develop in-depth knowledge in relevant therapeutic areas and maintain understanding of relevant competitors by attending scientific meetings and reviewing literature
• Critically review and summarize literature to support document development (e.g., protocols), new indications for a given molecule, competitive intelligence and continual learning
• Assist in preparing materials for Investigator meetings, advisory boards, conference activities, external collaborations, and partnerships
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