Associate Director, Clinical Scientist

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