• Lead the Program Management, Strategy & Enablement organization. • Responsibilities include oversight of the Program Management, Clinical Learning & Development, Compliance and Acquisition/Integration Teams. • Additional responsibilities include refinement/development of processes, support of value improvement projects, participation on audit/inspection readiness teams, corrective and preventative action teams, and support of annual operating & strategic planning.

Responsibilities include leading clinical teams through integration planning and facilitating integration related implementation activities for new acquisitions.

Responsible for leading Clinical Due Diligence for potential acquisitions and planning/facilitating the integration of clinical trial operations for new acquisitions.

• Coordinated and led an investigator-initiated research (IIR) program (approximately 85 clinical and non-clinical studies).• Responsibilities included coordinating and leading monthly steering committee review meetings. • Managed study budgets including accruals and ongoing forecasting of approximately 500 milestone projections. • Collaborated in the development of a web-enabled software solution that facilitated the submission, review, approval, tracking and financial management of IIR studies for internal stakeholders. • Acted as a liaison with the Publication Planning Group regarding strategies for abstracts and manuscripts.• Participated in the development of a Phase 3b/4 strategic plan in conjunction with the Medical Affairs Medical Directors, and other key functional team members.• Participated in the development of processes and standard operation procedures for IIR studies.

• Responsible for design, implementation and overall management of clinical studies.• Collaborated with Key Opinion Leaders. • Led project team meetings.• Coordinated activities between functional teams (clinical, monitoring, safety, biostatistics, data management, marketing, research & outcomes planning, regulatory, quality/complaint management/vigilance and business operations), investigators, CROs, and core labs. • Participated in protocol/CRF development and development of study reports. • Prepared reports for submission to regulatory agencies. • Ensured investigator compliance with good clinical practice, laws and guidelines. • Provided work direction for Clinical Research Associates, Project Coordinators and Clinical Monitors. • Managed project budget and timelines. • Contributed to ongoing departmental and procedure development/enhancement processes.

• Directed and managed career development of several staff-members, including CRAs and project coordinators.• Assisted with the management activities of several clinical protocols including planning, implementation, tracking, and assessment.• Supervised the site-management activities of a number of contract and in-house Clinical Research Associates ensuring comprehensive, efficient and timely management of projects.• Assisted with the training of new CRAs and conducted project team training sessions. • Participated in and lead project team meetings, developed project templates, tracked site visits and managed documentation collection.• Managed safety and data collection of ongoing Investigator-Initiated studies. • Aided in the development of processes and templates.