Danielle Rudolph

• Collaborate with the executive team on overall company strategy, focusing on clinical development and operations. • Lead operational delivery of clinical development programs, managing budgets and project milestones effectively. • Analysis of scientific literature to evaluate the competitive landscape and monitored industry trends in regenerative medicine/biopharma.

• Managed clinical activities for hyaluronic acid (HA) product portfolio, overseeing international research studies in Asia. • Led clinical trial audits, reviewed regulatory documents, and designed clinical protocols for OrthogenRx. • Managed budgets for clinical programs, reviewed vendor proposals, and participated in Quality Assurance and R&D team meetings.

• Led clinical development program for novel stem cell start-up, procuring human trophoblastic stem cells (hTSCs) for commercialization • Oversaw study start-up activities in the USA and Asia, securing financing in 2015 to accelerate research objectives • Managed budget and project milestones, overseeing all IRB-related activities

• Led clinical research studies in Orthopedics (Spine) and Oncology, including IDE, IND, registry, and post-marketing studies. • Provided clinical consultation on various research projects for Surgical Research Solutions, LLC in the Greater Los Angeles Area. • Prepared and delivered presentations to medical communities and organizations to share research findings and insights.

• Developed relationships with National and Regional Key Opinion Leaders in Pediatric Hematology/Oncology and Hematology/Oncology fields. • Managed research and educational activities at targeted institutions. • Identified opportunities for clinical research consistent with company objectives and strategies. • Acted as a liaison for cooperative group clinical projects.

• Developed relationships with Key Opinion Leaders in Hematology/Oncology, fostering scientific inquiries and collaborations. • Acted as a liaison for National Accounts like Kaiser Permanente, working closely with Oncology Account Managers. • Presented at scientific conferences and conducted business intelligence for Medical Affairs and Clinical Departments.

• Oversaw clinical research protocols for orthopedic spine surgeons at multiple hospitals, ensuring compliance and accuracy in data collection • Drafted Clinical Trial Agreements with medical providers and device companies to facilitate research collaborations • Managed multi-center collaboration studies, attended research-related procedures, and trained research employees on protocol adherence

• Cultivated relationships with Key Opinion and Thought Leaders in Medical Oncology, Radiation Oncology, and GYN Oncology. • Developed investigator-initiated clinical studies across various cancer types. • Collaborated with Western Regional Business Director and Oncology Sales Specialists on target accounts. • Published abstracts and manuscripts for prestigious medical conferences.

• Supervised and coordinated Contract Research Organizations, Contract CRAs, and Central Laboratories for Neuro-Oncology trials. • Managed Phase III trial with 45 sites and Phase II trial with 32 sites for CNS malignancies. • Drafted and reviewed Request for Proposals and Annual Reports for clinical studies. • Prepared regulatory documents and managed European Oncology Clinical Trials for NSCLC and Hematologic Malignancies.