Description

• Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical programs in early and late-stage oncology
• Creates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and quality metrics during study startup, conduct and closeout
• Work effectively with procurement and scientific leads to execute contracts and statements of work to meet program deliverables
• Contributes to central lab setup and management throughout the course of a study
• Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are processed, tested and data is reported to meet development timelines and specifications
• Works closely with data management to establish data collection and transfer processes with testing vendors and local labs
• Contributes to the preparation of clinical documents such as clinical protocol, clinical study reports, lab manuals, informed consent forms, sample management plan, early development plans and site training materials
• Works with scientific stakeholders to identify innovative bio sample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards
• Develops presentations and shares biomarker plan, project timelines, sample tracking/testing metrics at regular team meetings
• May work with scientific stakeholders to evaluate and implement new assays and relevant technologies as required by the program
• Manages relationships with internal and external partners to ensure on-time and quality deliverables
• Participates in cross-functions study team meetings across clinical, translational research and diagnostics.

Qualifications

• A bachelor’s degree in a scientific/ life science discipline is required. Additional qualifications: e.g. MS, PhD and/or project management certification desirable.
• 5+ years of work experience in clinical development, and/or biomarker or diagnostics development and/or Pharmaceutical/biotech R&D
• Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP required
• Project management experience is preferred
• Knowledge of oncology drug development and/or biomarker/diagnostic development is preferred
• Excellent written and verbal communication skills
• Ability to effectively and collaboratively work on global cross-functional teams