ABOUT ME
Program Management/Clinical Operations professional with 37 years of experience within the pharmaceutical, biotechnology, and CRO industries. I’m a professional who understands how to quietly influence and lead cross-functional international teams in a direct line and matrix environment. Consistently brings excitement to the project/program, motivation, customer or team satisfaction, ensuring compliance with ICH/GCP, implement successful enrollment strategies, and produce quality to meet development and corporate strategies, stakeholder expectations, and profit targets reporting to and working with C-Suite and Virtual FSP models.
Start-up Biotech
Guiding biotech startups toward scalable success.
Project/Program Management
Leading projects efficiently from start to finish.
Clinical Operations
Streamlining processes for clinical trial excellence.
ICH-GCP
Ensuring compliance with global clinical standards.
MY MISSION
Excellence is not a goal,
it’s how a team works together.
PERFORMANCE-ORIENTED RESULTS
Therapeutic Experience
Our extensive experience spans a variety of therapeutic areas, supporting clients with specialized knowledge and a proven track record in each field. Key areas of expertise include:
Oncology/Hematology
13yrs
Cardiovascular/Metabolism
13yrs
Rare Disease
8yrs
General Medicine
8yrs
Central Nervous System
7yrs
Controlled Substances
2yrs
ACHIEVEMENTS:
Develop, build, and implement organizational infrastructure to allow for growth and process improvement, whereby allowing the organization to work efficiently and effectively
Cross-functional leadership and development for global teams in NA, LA, EMEA, and APAC (65 countries) inclusive of multiple CROs and vendors
Portfolio values from $1M to $1B
Strategize efficient and proven effect process to improve timelines inclusive of enrollment to align with original projections and provide strategies
Streamline programs to consistently develop high performing teams, high quality data, vendor efficiency, relevant study documents, and recover financial overspend in accordance with ICH/GCP, GDP, GMP, vendor SOPs, and local regulations
Inspection readiness for BIMO and PAI; mentored cross-functional teams to ensure out of 244 audits and/or inspections by FDA, MMA, TGA, and Health Canada, no major or critical findings were reported
7 NDA and one BLA approval
Master Certificate for Project Management from Villanova University
$1M - $1B Portfolio Values ✦ 7 NDA and one BLA Approval ✦ Inspection Readiness for BIMO and PAI ✦ High Quality Data ✦ Vendor Efficiency ✦ Improve Timelines ✦ $1M - $1B Portfolio Values ✦ 7 NDA and one BLA Approval ✦ Inspection Readiness for BIMO and PAI ✦ High Quality Data ✦ Vendor Efficiency ✦ Improve Timelines
Expertise and Skills:
Relationship Development
Building strong, strategic partnerships globally.
Communication
Clear, effective messaging across teams and stakeholders.
Collaboration
Driving success through teamwork and unity.
Leadership
Inspiring and guiding teams toward objectives.
Budget/Financial Management
Strategically managing resources to meet goals.
Presentations
Proven experience in leading cross-functional and global teams toward shared goals and measurable outcomes.
Vendor Management
Optimizing vendor relationships for efficiency.
ABOUT:
Program Management/Clinical Operations professional with 37 years of experience within the pharmaceutical, biotechnology, and CRO industries. I’m a professional who understands how to quietly influence and lead cross-functional international teams in a direct line and matrix environment. Consistently brings excitement to the project/program, motivation, customer or team satisfaction, ensuring compliance with ICH/GCP, implement successful enrollment strategies, and produce quality to meet development and corporate strategies, stakeholder expectations, and profit targets reporting to and working with C-Suite and Virtual FSP models.