Rachel Woloski

WORK HISTORY

EDUCATION

SKILLS

ABOUT RACHEL WOLOSKI

Highly motivated Senior Clinical Operations Director with experience building out clinical development operations department capabilities and a proven track record of developing and implementing new processes, preparing for regulatory inspections and delivering sought-after quality assurance insight. Adaptable and comfortable in fast-paced environments, able to quickly adjust priorities and implement effective solutions.19 years of pharmaceutical/biotech experience including:• Operational strategy development (site numbers, timelines and budget planning)• Department resourcing and budget projections• Vendor management and oversight at relationship level• Regulatory inspections, inspection readiness, audit conduct and responses• Quality Management Systems, SOP development, risk-based quality management, CAPA and global and study level QA plans• Department, Program and Study budget planning and management• Therapeutic areas: Oncology, CNS• Small molecule, biologics and radioligand therapy • Dose escalation and expansion, pivotal, platform, global trial management • Start-up biotech environment Achievements: • Built out operational team and capabilities from scratch for start-up radiopharmaceutical company with a mixed resourcing model of in-house full time team members, contractors specialty consultants. Implemented timeline and budget management, global development teams, and standardized processes.• Successfully developed site and vendor regulatory inspection program for a submission of a clinical development program that included 5 studies, created site selection algorithm that accurately predicted sites selected for pre-approval inspection and developed study level risk tools for both quality assurance and clinical operations.