Associate Director, Clinical Scientist

Company Description

Bicycle Therapeutics is a clinical-stage biopharmaceutical 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 BT8009, a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC 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, MA.

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 or immunology 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 the clinical department working to advance Bicycle® Toxin Conjugates and Bicycle® Immune Agonists as novel cancer therapeutics. The Clinical Scientist will report to the Head of Clinical Sciences within clinical development and closely interact with the medical director(s) as well as with the biostatistics, regulatory, translational, and discovery/preclinical groups to facilitate execution of early phase studies and development of next phase clinical trials. This position will interface externally with study sites, investigators, advisors, and contract research organizations (CROs). 

• Responsible for clinical study design and conduct for development of novel tumor antigen-targeted Bicycle® therapeutics
• 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
• 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
• Serve as a liaison between study team, CROs, and investigators
• Track study progress and metrics related to emerging clinical data
• Contribute to regulatory documents, including INDs and briefing books and other regulatory documents
• Enable translational medicine by working closely with biomarker and discovery scientists
• 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
• Contribute to publication strategy and provide support for publication of data
• Assist in preparing material for advisory boards, conference activities, external collaborations, and partnerships
• Support internal initiatives to develop best practices, lessons-learned, problem-solving, and risk mitigation
• Potential to mentor other clinical scientists
• Attend congresses as needed to support publications as well as interactions with key opinion leaders and investigators

Qualifications

• Life sciences MS or PhD or health degree such as nursing or pharmacy
• Extensive experience working as a clinical scientist in oncology
• Clinical study design, data collection, analysis, and data interpretation skills
• Knowledge of Good Clinical Practice (GCP) and basic regulatory principles
• Experience with technical writing for scientific, regulatory, and/or clinical documents
• Excellent written, oral communication and presentation skills
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