VP, Biometrics

## Company Description **About Bicycle Therapeutics** 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 nuzafatide pevedotin (formerly BT5528), a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; a pipeline of Bicycle® Radioconjugates (BRCs) and imaging agents;; zelenectide pevedotin (formerly BT8009), a BDC® targeting Nectin-4, a well-validated tumor antigen; and, through various partnerships, the use of Bicycle® technology to develop therapies to treat diseases in a range of therapeutic areas. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Massachusetts, USA. 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 The Vice President, Biometrics will build, resource, oversee, and play a hands on role for the Biometrics organization. This leader holds ultimate accountability for clinical study designs, statistical methodologies, data analysis, and interpretation of results in close collaboration with partner functions across Clinical Development, Operations, and Regulatory Affairs. As a key member of the Development Leadership Team, the VP provides strategic statistical input into Bicycle's drug development portfolio, representing the company in interactions with global Health Authorities (FDA, EMA, MHRA, RoW agencies) and contributing to the advancement of our oncology and radiopharmaceutical clinical pipelines. Additionally, this role supports early-stage research and translational sciences as required. The ideal candidate possesses deep global clinical development expertise in oncology, combined with an outstanding track record of managing complex portfolios, driving innovation in applied statistical methodologies (including adaptive designs), and leading teams in a high-growth, agile biotechnology environment. Experience in Bayesian Trial design and radiopharmacology experience is preferred. **KEY RESPONSIBILITIES** - **Operational Leadership:** Ensure highly effective and compliant global operations in biostatistics and clinical/statistical programming, establishing industry-best standard operating procedures (SOPs). Maintaining inspection-ready documentation and ensuring ICH GCP compliant, demonstrable data flow and data governance stewardship across the portfolio - **Strategic Input:** Lead and actively contribute to Biometrics participation in clinical development plans (CDPs), clinical protocols, investigator brochures, regulatory briefing documents, and scientific publications. - **Statistical Integrity:** Drive the development, implementation, and execution of robust statistical analysis plans (SAPs) that support clinical protocols, ensuring absolute data integrity, accuracy, and regulatory compliance. - **Radiopharmaceutical and BRC Support:** Provide specialized statistical guidance for the expanding Bicycle® Radioconjugate (BRC®) portfolio, incorporating imaging endpoints, dosimetry analysis, and theranostic study designs. - **CRO & Vendor Management:** Oversee the strategic selection and management of CRO partners, holding accountability for the quality,…