Deborah Strahs Email & Phone Number

Sunnyvale, California, US

• Manage new molecule through IND process to First Patient In (FPI), ensuring all regulatory requirements are met.
• Provide ongoing clinical trial support for two molecules, optimizing trial execution and problem resolution.
• Mentor and support cross-functional team members to ensure smooth trial operations.
• Minimize time to First Patient In and Study Closeout. Maintain high quality after reduction in force.

South San Francisco, California, US

• Manage First in Class/ First in Human oncology molecule to have first site up and running before outside vendor services started. Coauthored protocol, and collected/prepared documents for IND. Reorganized internal and.
• Negotiated budgets and reduce overall vendor expenditures by $4M
• Mentor and develop team members and provide cross functional support to optimize performance and communications

• Led clinical operations efforts for a First-in-Class oncology molecule, including protocol co-authorship and IND preparation.
• Reorganized internal and external clinical operations teams to improve Phase 1 study reporting and vendor management.
• Negotiated vendor contracts, reducing overall costs by $4M and ensuring timely study start-up.
• Mentored team members, provided cross-functional support, and optimized team performance.

Burlingame, CA, US

• Led clinical operations for Phase 1 and 3 studies in oncology and infectious diseases.
• Led adaptive design studies, pivotal Phase 3 trials, and global study closeouts, ensuring alignment with organizational goals.
• Managed CRO/vendor relationships and study budgets for two molecules, achieving milestones within budget and on time.
• Developed SOPs, training materials, and study related plans, ensuring adherence to GCP guidelines and quality standards.
• Provided leadership for clinical operations staff, resulting in 8 promotions within the team of 5.

• Built the clinical operations department from the ground up, including SOP development, vendor selection, innovative training materials, and study planning.
• Successfully achieved First Patient In (FPI) within one week of clearing the FDA 30-day window for IND submission.
• Managed multiple vendors (domestic and international) and established a robust QA plan for vendor oversight.
• Led cross-functional meetings to ensure alignment on clinical operations goals and timely execution of trial milestones.

South San Francisco, CA, US

• Managed global clinical studies, ensuring adherence to SOPs, timelines, budgets, and GCP regulations.
• Led CRO/vendor selection processes, ensuring quality and performance through ongoing management and oversight.
• Provided strategic direction to internal teams, resolving clinical trial issues and ensuring consistent progress.
• Managed clinical supply forecasts and coordinated the timely delivery of trial materials across global sites.

South San Francisco, California, US

• Managed global Phase I and II clinical studies across multiple regions, including Latin America, Eastern and Western Europe, Australia, and Israel.
• Mentored junior staff, ensuring effective knowledge sharing and operational consistency across teams.
• Worked with KOLs on investigator-initiated studies and developed strategies to address study-wide issues.

US

Help design and implement clinical trials for a new product.

Foster City, CA, US

• Assisted in the management of Phase III pivotal studies for HIV therapeutic treatments on a global level.
• Led vendor management, recruitment strategy development, and troubleshooting of study-wide issues.
• Supported contract negotiations and facilitated the timely resolution of operational issues across study sites.

South San Francisco, California, US

• Managed operational activities for Phase II & III pain studies, including protocol development and siterecruitment.
• Led vendor selection, organized investigator meetings, and ensured timely study start-up and close-out.

Bedford, MA, US

Clinical Project Manager (Consultant). Manage all aspect of clinical trials for company's medical devices trials through contracted work period.

Cambridge, MA, US

Phase I- III oncology protocols that were either investigator initiated or company sponsored. Facilitate internal approvals to get sites up and running quickly; assist with protocol review; keep track of milestones; manage all financial aspects and communications with the sites. Temporarily filled Scientific Advisor role meeting with local KOLs while new.

US

Managed time sensitive projects in oncology (ovarian); multiple sclerosis; and psoriasis. Exceeded expected enrollment rates; trained staff, and facilitated the implementation of new processes to streamline existing work flows.

Austin, Texas, US

US