• Successfully transitioned to role of Senior manager and primary contact for 7 on-going clinical trials, at various stages of completion, managing multiple CROs.• Managing start up for 2 Oncology programs. A Phase 1, relapsed/refractory acute myeloid leukemia (AML) study and a Phase 1 / 2, Relapsed Metastatic Solid malignancies.

• Conduct instructor-led training for the "Clinical Research Associate and Clinical Research Coordinator Training: Roles, Responsibilities, and Career Opportunities" course.• Target audience includes new CRAs/CRCs aiming to enhance their skill set and individuals seeking insights into the pharmaceutical industry.• Deliver a comprehensive 10-week course via WebEx, over 3 hours each week.• Previously hosted training sessions at Villanova University, Raritan Valley Community College, Rutgers University, West Chester University, and Arcadia University.

• Led comprehensive oversight of two large-scale, phase 3 global clinical programs aimed at establishing a new indication for treating chronic rhinosinusitis, managing all facets including selection and supervision of two contract research organizations (CROs) and vendors, country/site selection, recruitment, monitoring, regulatory submissions, and safety management.• Successfully orchestrated the completion of two global registration studies featuring complex entry criteria, working across 12 countries from Start- up through to closeout.• Directed project management and controlled budgets of up to $40M, ensuring efficient resource allocation and financial accountability throughout the clinical trials.• Managed a proficient clinical team comprised of a project manager and two Senior CRAs, ensuring the cohesion and effectiveness of the team's efforts.• Strategically navigated challenges posed by the COVID-19 pandemic by initiating protocol amendments to the FDA and global health authorities, facilitating the continuation of operations through telehealth visits, reducing invasive exams, and enabling sites to directly ship study medication to patients.• Served as the primary point of contact for quality assurance processes, overseeing audits and audit plans while ensuring compliance and quality standards were consistently met.• Mentored and trained Clinical Research Associate in conducting and monitoring Phase 4 clinical trials within Medical Affairs, collaborating with the Medical Affairs team on Investigator Initiated Studies.• Contributed as a key team member for IND and NDA submissions, participating in the development of standard operating procedures (SOPs) for clinical development, periodic safety reviews, and annual Investigator Brochure (IB) revisions.

• Transitioned from initial assignment with Endo Pharmaceuticals to a full-time role, leading clinical operations teams. Responsibilities included resource management, program assignments, and hiring.• Spearheaded initiatives aimed at process improvement and communication enhancement, reviewing, and refining standard operating procedures (SOPs).• Improved efficiency by streamlining operational processes.• Pioneered the establishment of Function Service Provider teams across three separate companies.

• Led clinical operations at Endo Pharmaceuticals, managing resource allocation, program assignments, and recruitment.• Directed departmental and program budgets while overseeing contract research organizations (CROs) and vendors.• Revised and improved standard operating procedures (SOPs) to enhance operational efficiency.• Managed, mentored, and oversaw a multidisciplinary clinical team consisting of 3 Associate Directors, project managers, and CRAs.• Spearheaded the development and supervision of departmental and program budgets.• Initiated and executed strategies to optimize processes and enhance communication within the team.• Successfully launched a clinical trial, collaborating with the study team to ensure adherence to SOP, FDA, and ICH guidelines throughout program implementation.

• Ensured study launch, conduct, and closeout compliance within contractual agreements, acting as a liaison between the company and clients. • Reviewed study budgets and expenses, administering all contract and financial aspects.• Created and distributed status, resourcing, and tracking reports.• Managed communication with customers and project teams, providing regular progress reports and documenting all communication.• Supervised a team of six employees, including employee development and performance management.• Mentored and collaborated with several PMs.• Successfully turned around a failing study into a productive one, resulting in client satisfaction and bids for repeat business.

• Managed a cross-functional team of four employees, mentoring on operational activities.• Oversaw CROs and vendors both domestically and internationally.• Administered project budgets and acted as the primary point of contact for internal stakeholders.• Created and managed study timelines ensured compliance with SOPs and monitored performance/quality metrics.• Developed and delivered study-specific training.• Took over a clinical project mid-stride and delivered the clinical trial on time by collaborating with CRO and the study team.• Utilized innovative methods to find patients for rare disease studies by attending conferences and setting up booths to recruit potential study sites.

• Acted as the Therapeutic Lead for Cardiovascular/Inflammation/Immunology (CII) studies.• Oversaw operational activities, managed and mentored associate directors and clinical project managers.• Conducted domestic and international oversight of CROs and vendors.• Developed program/project budgets and advised on operations budgets.• Led efforts to update SOPs and processes with several teams.• Oversaw and directed work on approximately 15 protocols.

• Established a resourcing group for clinical operations to address resourcing needs.• Managed approximately 100 CRAs (equivalent to 50 FTEs).• Interacted with study teams to regionalize the CRAs for increased efficiency and cost savings.• Collaborated with IT&S to develop a Monitoring Calendar for tracking site visits and RCRAs' unavailable time.• Established a Monitoring visit report process and tracking system in conjunction with IT&S, including writing, review, and finalization of reports.• Worked closely with the Training Group to assist with Role and SOP training for current and new CRAs.• Conducted co-monitoring visits with RCRAs for evaluation and process management purposes.• Actively participated in Program and study team meetings, sharing information about RCRAs, gathering details on upcoming timelines, and staying updated on various projects.• Planned and delivered presentations at National Operations Meetings with a focus on training and interaction with the program team.• Created, reviewed, and updated processes and procedures to enhance the partnership with Functional Outsourcing Partner, resulting in improved efficiency and increased quality.

• Therapeutic Lead for Pain in operations.• Played a key role in IND, NDA, and clinical development teams, drafting timelines and development plans.• Directed clinical project coordinators and managed CROs and vendors.• Administered four pain programs concurrently and filed sNDA for a pain product.• Served as the Clinical Operations team member for multi-disciplinary Project team for all Pain Products.• Created study budgets for Therapeutic Area Medical Lead for proposed pain studies.