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® Drug Conjugate (BDC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC 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® Radioconjugates (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. For more information, visit bicycletherapeutics.com.

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

Scientific Strategy & Innovation

• Participate 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 plans
• You 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 intelligence
• You will develop innovative solutions to cross-functional challenges.

Project Delivery & Execution

• Contribute to clinical study design and conduct for development of novel tumor antigen-targeted Bicycle® therapeutics
• Lead medical and safety data review and associated meetings in collaboration with the Medical Monitor, review and query data
• Participate in study start up, including identification of investigators/sites, feasibility, review of CRF, etc
• Develop content and give presentations during site initiation visits; participate in site training
• Support internal initiatives to develop best practices, lessons-learned, problem-solving, and risk mitigation
• You 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 & Compliance

• You 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 documents
• Contribute to publication strategy and provide support for publication of data
• You 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 int