Andrew Leone

About Andrew Leone

Highly motivated, patient-centered professional seeking opportunities within the Pharmaceutical, Biopharmaceutical, and Healthcare industries. Working within REMS since 2018. Experienced in supporting multiple REMS (Risk Evaluation and Mitigation Strategy) programs across three therapeutic areas, with a strong focus on immunotherapies, hematology/oncology (including CAR-T and IMiDs), bispecifics, and cardiology.Skilled in quality assurance, project management, research, analytics, training, and relationship management, with a commitment to continuous growth in these areas. Recognized for a strong work ethic, a true “patient-first” mindset, and the ability to thrive in diverse, fast-paced environments. Proven track record of demonstrating flexibility, dedication, mentoring, innovative problem-solving, and collaboration across all previous roles.

Experience

1. Clinical Project Research Manager, Rems

   UBC

   Apr 2024 — Present · King of Prussia, PA, US

   Oversee all aspects of project conduct from start-up through close-out• Execute operational aspects of assigned project activities as well as special projects • Manage projects per the scope of work (SOW) and within the contracted budget• Manage revenue and invoicing of projects• Ensure projects are conducted according to UBC SOPs as well as any external applicable SOPs• Develop plans and processes to achieve contracted milestones (ie. project plan, clinical management plan, monitoring plan, training plan, communication plan, compliance plan); monitor project progress against the established plans and ensure compliance with set plans• Prepare project timelines; prepare and coordinate development of deliverables • Prepare project meeting agendas, facilitate meetings, create meeting minutes and goals/ action items. • Ensure project budget is tracked against contract milestones• Serve as UBC primary contact with the contracted sponsor(s)• Coordinate and facilitate all project meetings with internal and external stakeholders as necessary• Focal point for resolving project team member questions• Supervise all functional areas that suport the project• Lead projects with cross functional involvement and supervise all functional areas that support theproject• Ensure project training occurs and assist with training• Develop content and lead Kick off Meetings (KOM) both internaly and externally• Maintain project documentation to be \"audit ready\", practice GDocP and ALCOA+• Participate in sponsor/regulatory audits• Assist in in the protocol development for REMS Programs, Software and Supporting Documents• Help lead process improvement activities• Establish, implement and track key metrics to report on progress

Education

• Kean University

  Bachelor's degree, Political Science and Government

  2012 — 2015

• West Virginia University

  Political Science and Government

  2010 — 2012