Carole Ann Moore

• Independently lead Bluejay Therapeutics from a preclinical stage to clinical stage, initiating multiple first in human studies, resulting in quality data being presented at EASL and AASLD in 2023, 2024 and 2025.
• Reporting directly to the Chief Medical Officer, responsible for all aspects of clinical study development and execution through leading cross functional teams and CROs for multiple molecules and indications, ensuring delivery within timelines defined by corporate goals.
• Oversight and responsibility for Clinical Operations budget, including negotiation with CROs, oversight of individual study budgets, partnering with an accounting firm for development of quarterly models, forecasting future spend and preparation for financial audits.
• Incorporated and managed Bluejay Therapeutics Australia, Pty Ltd. subsidiary for the RTDI benefit program, leading to over $5M in tax return from the ATO.
• Overseeing the transition from the manufacturing of Drug Products to Packaging and Labeling, strategizing clinical supply plan, conservation, allocation, and oversight of RTSM integration and utilization.
• Responsible for overseeing all study start-up activities, study execution, data management, and biostatistical and pharmacovigilance activities for multiple molecular entities and clinical studies.
• Resource planning, hiring and mentoring of additional Clinical Operations personnel, while demonstrating proficient leadership.

Reported directly to the VP of Clinical Operations and served as an integral part of the leadership team, responsible entirely for the Oncology Division (5 oncology studies, Phase 1-3) with additional supportive oversight of Phase I/FIH studies for new molecules, Hepatic Impairment Phase I study, clinicaltrials.gov policy and compliance, TMF policy and management, implementation of new portals/systems and early adopter and SME leader for GDPR.

• Additional responsibilities included direct line management of up to 10 director reports including CTMs, CRAs, and CTAs, mentoring, departmental initiatives, budgets, CRO selection and management, oversight of study start-up activities, primary analysis database lock, attending QA site audits, and partnering with other functional areas including serving as ClinOps representative to Medical Writing, developing, and managing timelines, review of SOW and invoices, and served as COVID-19 Task Force Leader.
• Partnered with clinical development, medical writing, and KOL to redesign of a Phase I ACC study to overcome obstacles to enrollment leading to fast enrollment upon amendment of the protocol.
• Partnered with Finance in the management of the entire Oncology budget including year-end re-forecasting, quarterly accruals, and true ups.
• Independently built an in-house Regional Monitoring Team, including hiring a Regional CRA Manager, partnering in the development of processes, monitoring KPIs and SOPs. Corcept was able to transition from an outsourced model of modeling to entirely using the in-house team for the US region.

• Hiring and management of 8 direct reports (Director, Associate Director, and CTM level) and 4 contract CTMs, developing job descriptions, aligning new positions within the existing team, and ensuring the responsibility matrix is efficient and effective.
• Created and led a Functional Area Task Force comprised of departmental VPs to develop and refine corporate and departmental processes, communication pathways, and SOPs for Phase 3 preparation.
• Partnered with underperforming CRO in creating the Executive Oversight Committee leading to CRO taking more responsibility and resulting in renegotiated budget credits and refined SOW.
• Worked with Finance to develop an efficient system for the oversight and management of the Clinical Operations budget.
• Partnered with MCO on DDI, Phase 2, and Phase 3 study strategy and design, including budget analysis.
• Gathering input from key opinion leaders, both physicians and basic scientists, leading to defining endpoints and study design for a large global Phase 3 study.
• Responsible for corporate clinicaltrials.gov policy and brought the company into compliance.
• Key Accomplishment: Hired 4 Clinical Operations direct reports in 3 months. Partnered with VP of QA to launch an SOP Task Force and BIMO Preparation Initiative. Implemented the first Cross Functional Study Management Team meetings leading to effective and efficient communication for Phase 2 and 3 studies.
• Optimized project timelines by effectively delegating tasks and prioritizing workload among team members.

• Director of Clinical Operations | RenovoRx September 2013 – January 2015
• RenovoRx is a start-up medical device/pharma company. As a founding partner in 2013, I served as the first Clinical Operations employee.
• Wrote a post-marking surveillance Plan and Protocol for inclusion in the Clinical Evaluation Report and CE Mark Submission.
• Partnered with KOLs to develop a dose escalation strategy for FIH TAMP.
• Worked with Medicare to define the reimbursement strategy for receiving approval for the use of ICD 9 codes.
• Wrote the ICF and managed all study start-up activities for Phase 1 and Phase 3.
• Worked with contract statisticians to develop a SAP.
• Hired and trained a database coordinator to build an eCRF.
• Hired and trained several consultants, including CTMs and CRAs.
• Wrote and instituted relevant SOPs.
• Key Accomplishment: Developed a First in Human, Phase 1 novel clinical study design for the local delivery of Gemcitabine directly to the pancreatic tumor utilizing a dual occlusion catheter. I wrote the clinical trial protocol and fully implemented the study, with full Medicare reimbursement. Positive outcomes led to Boston Scientific partnering with RenovoRx to launch the Phase 3 study. In 2013 I was working part time. In 2018/2019 I was contacted to re-join RenovoRx to launch the Phase 3 study. My efforts have led to the successful launch of the Phase 3 study in the US and the EU, defining the personalized patient and treatment pathway at each site to gain access to the most qualified patients.
• Facilitated knowledge sharing among staff through organized training sessions, workshops, and conferences on best practices in clinical operations management.
• Oversaw clinical studies focused on quality assessment, financial health and customer relations.

• PRC Clinical is a small, boutique CRO. I started as a contractor and was promoted to have more overall company responsibilities.
• Executed several regenerative medicine clinical studies serving as the sponsor’s main point of contact and managing a small team of internal CRAs and CTAs.
• Evaluated and managed project budgets and ensured units utilized were in alignment with the allocation in the SOW.
• Worked with Business Development in communications with new potential partners and presented at bid defenses.

• As a Contract Senior Clinical Trial Manager, I worked on several oncology studies and Alzheimer’s disease studies.
• Managed all aspects of Phase 2 clinical studies, running the SET (Study Execution Team Meetings), and collaborating cross-functionally to ensure the studies were executed with quality, according to timelines and budgets.
• Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.

• Janssen Alzheimer Immunotherapy is a mid-sized company that was a subsidiary of Johnson and Johnson.
• Independently led and managed a Phase 3 roll-over extension study (1500 patients in 8 countries), responsible for developing an efficient roll-over process and entire oversight of the study, including management of a major CRO and 14 vendors.
• Led the Study Execution Team (SET) to ensure that trial timelines, costs, and quality metrics were met.
• Served as primary clinical operations contact for functional area representatives in managing protocol execution and maintained open communication channels with study sites and study team members.
• Ensured accuracy and timeliness of vendor and site payments.
• Established study milestones and ensured accurate tracking and reporting of study metrics.
• Performed ongoing vendor management (e.g., CROs, IVRS, Imaging), including independent negotiation of scope of work, budgets, performance management, and issue resolution.

• Served as a temporary contractor to launch and execute a Phase I study of sodium oxybate in narcoleptic patients and a Phase 3 study of a Schedule II agent for the treatment of Fibromyalgia.
• Responsible for vendor selection, study start-up procedures, training materials, training CRAs and study site staff, ongoing study management, and database lock.

• Short-term temporary contract part-time position serving as a study manager for two small ongoing studies.
• Phase 1 dose escalation study of a cardiovascular agent for the treatment of acute decompensated heart failure.
• Manager of an ongoing long-term cardiovascular registry study.

• Contract position in the Medical Applications Research department working on post-marketing and investigator-initiated studies.
• Writing of a post-marketing protocol for an approved bronchodilator in COPD patients.
• Medical writing of a CSR for a clinical experience study of an approved asthma medication.
• Management of numerous Phase IV Post Marketing Investigator Sponsored Studies including review of proposals, ensuring funding of approved studies, managing of study start-up activities, and reviewing and writing of abstracts of final data with investigators.