Director, Translational Sciences and Diagnostics

Director, Translational Sciences and Diagnostics

Bicycle Therapeutics

Cambridge, United Kingdom

Job Description

The Translational Sciences and Diagnostics department is looking to hire a Director to support and oversee the development and execution of Translational strategies for our emerging pipeline of preclinical Bicycle Drug and Radio-conjugate programs. In collaboration with our Research and Innovation (R&I) colleagues, the successful candidate will be responsible for advising on target selection, developing predictive and pharmacodynamic (PD) biomarker strategies, including developing PK-PD-E modelling, and investing in clinical biomarker assay development to support pre-clinical assets from concept to Candidate Selection. Execution of the duties of this role will require co-ordination of activities supporting biomarker strategies internally within and across the Translational Sciences and R&I departments as well as managing scientific studies with a range of CRO’s, external collaborators and clinical investigators. The aim of these studies will be to gain a deep understanding of portfolio asset MOA alongside development of patient stratification and/or PD biomarkers. This position will report to the SVP of Translational Sciences & Diagnostics.

• Contribute to early development of the Bicycle discovery pipeline as the Translational team representative for all preclinical programs as well as new target identification efforts;
• Own development and implementation of biomarker strategies for all preclinical Bicycle Drug and Radio-conjugate programs;
• Identify pharmacodynamic assays for utility in pre-clinical and future clinical testing to help define PK/PD/efficacy relationships;
• Lead primary analyses of pre-clinical translational biomarker studies, including evaluation of patient selection strategies;
• Author and review the translational sections of regulatory documents (IND, clinical protocols) as well as scientific/clinical publications and present pre-clinical translational findings at scientific congresses;
• Develop effective working relationships across the Translational Sciences and R&I departments to manage diverse scientific studies with internal teams, CRO’s and external collaborators;
• Additional responsibilities as needed and directed.

Qualifications

Essential:

• MS or PhD (preferred) in biochemistry, molecular cellular biology, pharmacology, medical science, or related field;
• 5+ years of drug development experience in industry in oncology, including direct contributions to early drug development programs;
• Experience in developing biomarker strategies in oncology drug development, including knowledge of GCP;
• Outstanding track record of scientific achievement;
• Excellent verbal and written communication and organizational skills with demonstrated success in leading pre-clinical projects and interacting with cross functional teams;
• Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment.

Desirable:

• Experience in managing scientific teams and research in an externalized setting;
• Experience with authoring pre-clinical biomarker data packages as part of IND submissions;
• Knowledge and experience in developing preclinical packages for diagnostic imaging modalities;
• Familiarity with current biomarker regulatory frameworks in different regions.

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