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
