Cami Lau, PMP

• Leads and manages a team of direct and indirect reports • Provides Clinical Operations leadership oversight of assigned programs, including tracking and managing deliverables and working cross-functionally with key stakeholders to optimize processes related to studies and in an effort to streamline timelines without compromise to quality study deliverables • Provides input into strategic and operational short-and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation • Establishes and maintains a strong collaboration and partnership with cross-functional colleagues globally to ensure timely, high-quality and within-budget delivery of programs • Provides strategic input into Clinical Development Plans that significantly influences the direction and outcomes of product development strategies • Plays a lead role in Clinical Operations and cross-functional organizational initiatives to drive ongoing efficiencies and operational excellence

• Managed multiple clinical studies within a program or multiple programs, including a large, global Phase 3 NASH program across two dozen countries • Led cross-functional study management team • Accountable for program timeline and quality metrics • Managed study resources and responsible for career development and guidance of direct reports • Initiated, participated in and/or led departmental strategic initiatives, including development of SOPs and Work Practices

• Managed and led Phase 2 and 3 clinical trials in Hepatitis C, including 5 studies in Japan--two of which have led to NDA approvals • Developed and coordinated execution of cross-functional study timelines • Coordinated development of study protocols • Managed CRO, lab, and IXRS vendors

• Successfully managed Phase 1, 2, and 3 clinical trials, ranging in budget from $3.8 to $6.8 million each, by ensuring that each proceeded on time and within budget • Maintained high customer satisfaction by serving as the primary liaison with the sponsor, and facilitated and coordinated work across internal departments and third-party vendors • Consistently maintained project realization above budget targets by monitoring progress using tracking and analysis tools; analyzed financial status of projects at least weekly; and presented study status and metrics at monthly review meetings with senior management • Improved efficiencies within projects and across a portfolio of over ten active projects by designing and implementing new tools and reports for the sponsor and fellow project managers • Represented the company at customer proposal defense meetings • Executed an accelerated start-up, with database live and site initiations within 5 weeks after the final protocol • Created a user-friendly modeling tool for forecasting site activation, patient enrollment, and data volume that was 10 times faster to set-up and is now required for all bid defenses within the department • Managed and supported professional development of four direct reports • Experience in Oncology trials: Acute Myeloid Leukemia, Bladder Cancer, Breast Cancer, Advanced Solid Tumors, and Ovarian Cancer

• Successfully managed the medical imaging portion of Phase 2 and 3 clinical trials, by ensuring that each proceeded on time and within budget (see Project Manager below) • Designed and led innovative process improvements and identified strategic opportunities, including creation of a standard reporting tool and enhancement of proprietary software • Identified strategic opportunities and assisted in the tactical management of the Musculoskeletal division • Supervised and standardized a portfolio of over a dozen studies for a sponsor, serving as the primary point of contact and escalation for the sponsor • Won new business by representing the company in bid defenses and capabilities presentations • Managed and supported professional development of five Project Managers and Supervisors

• Successfully and proactively managed up to seven clinical trials at once, ranging in budget from $400,000 to $1.8 million each • Maintained high customer satisfaction as the primary contact for clients and leader of several internal multidisciplinary teams • Managed study-specific documentation, tasks and deliverables, resources, financial tracking and control, and contingency and mitigation of risks • Structured site qualification, image collection, and independent review activities in compliance with GCP for oncology, central nervous system, and musculoskeletal trials (Phase 1, 2, and 3) • Served as the key operational interface between pharmaceutical or biotechnology clients and several multidisciplinary internal departments, including: imaging specialists, contracts associates, medical directors, regulatory team members, and software developers • Experience in Central Nervous System trials (glioma, multiple sclerosis, stroke), Oncology trials (hepatocellular carcinoma, lung cancer, colorectal cancer, thyroid cancer), and Musculoskeletal trials (obesity, osteoarthritis)

• Maintained databases of study documentation and medical images (CT, MRI, X-ray, bone scan) from international sites, and ensured compliance with study-specific guidelines • Performed computer-based analyses and preliminary measurements on medical images in preparation for the independent review • Interacted with investigator sites worldwide to ensure standardization of imaging across a trial • Assisted radiologists and oncologists during their review of the study images and clinical data

• Worked as a Research Assistant in the BioRobotics Laboratory • Developed and analyzed finite-element models related to the biomechanics of voice production • First author, “Compliant Background Subtraction Algorithms for Tactile Rendering,” in the Haptics Symposium 2004 • Vocal co-chair for the Crimson Crooners (MIHNUET--Music In Hospitals and Nursing homes Using Entertainment as Therapy)