Teaching Introduction to Clinical Trial Management.

Oversees and leads the Wave clinical operations team to ensure operational trial deliverables across programs are completed according to timelines, budget, operational procedures, quality standards, and SOPs.

Senior leader reporting to the Head of R&D/Chief Medical Officer, with responsibility for executive oversight and overall management of all study related operations activities, this includes the following functions:- Medical Writing- Clinical Operations- Clinical Data Management- Clinical Outsourcing and Vendor Management- Patient Recruitment and Retention- Clinical Development Compliance, SOP's and Inspection ReadinessKey responsibilities include:- Oversight, management, professional development, training and performance of all staff- Ensure all company policies and regulations are followed and adhered to- Provide strategic direction where needed, this includes how we select our vendors - Build an organization that is flexible, talented and able to efficiently deliver the trials for patients- Represent Clinical Development Operations at the CEO's Leadership Team- Participate in regulatory meetings as required- Ensure robust data quality approaches are in place for all studies- Develop country selection and site identification strategies- Interface and communicate with stakeholders and across functions- Budget forecasting and management oversight for all studies across - Member of R&D/CMO Senior Leadership Team

As the Head of Clinical Operations, I ensure that clinical programs achieve objectives within established timelines, budget and quality standards. I work with functional leadership to ensure appropriate company infrastructure and quality systems are in place to support all clinical trials. Our main deliverable is to execute clinical trials in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and ImmunoGen SOPs. Responsible for a multi-function department, which included: • Trial Operations• Clinical Outsourcing• Clinical Trial Drug Supply• Clinical Data Management• Site Contracts• Clinical Trial Office (eTMF management etc.)• Medical Writing• Operations LeadershipOther responsibilities include:• Responsible for staff allocations, utilization, SOP, Training, and compliance• Development, oversight and rollout of diverse strategic initiatives supporting clinical operations• Provide strategic direction for the department using innovation and focusing on core activities• Serve as a member of the CEO’s Senior Management Team (SMT)• Manage multi-million dollar budget for Clinical Development Organization• Participate in industry roundtables to learn from peers• Ensure all clinical trials are successfully executed with measurable results to include KPIs• Conducts performance reviews, calibration sessions and feedback discussions for direct reports• Built a high functioning Clinical Operations team• Supported several submissions• Worked on standardizing SOP's for Clinical Development• Enrolled Phase 3 clinical trial 2.5 months ahead of plan (15 months total)• Presented at CEO's Executive Committee • Ensured teams were motivated and fostered a positive work environment

Responsible for managing and staffing an organization of 60 employees responsible for strategy and execution of highly complex clinical trials in Multiple Sclerosis, Biosurgery, Opthalmology, and Rare Genetic Diseases. Direct management of Clinical Team Leaders and Trial Operations Program Managers (TOPM); Clinical Trial Operations Managers (CTOM) and Clinical Trial Associates are also part of the group. Our mission is to ensure clinical trials are delivered on-time with quality data and in line with GCP. As the leader of the group, my responsibilities outside of clinical trial execution includes resource management, budgets, staff development, local site leadership and creating opportunities where possible. Given my diverse background, I also provide leadership, mentoring and support during transition to CTOM role which combines clinical trial and data management responsibilities. Additional roles include:- Project Leader for Lemtrada overseeing operational strategy for R&D and Medical Affairs studies- Clinical Trial Operatins Site Head for Cambridge Office- Champion for Data Management outsourcing ensuring deliverables are met and quality data provided - Leading several other initiatives including process for Sunshine Act and MSP- Voting member of Neurology Protocol Review Committee representing trial operations to ensure protocols are executable

Responsible for global operations strategy, oversight of clinical trial execution, budget management and delivery of multiple programs in MS (Ph I-IV). Member of Neurology Protocol Review Committee representing Clinical Operations and ensuring that protocols are executable. Oversight of all MS Projects and leader of operational reviews. Part of MS leadership team as the main interface between operations and clinical development/business unit.

Responsible for global operations strategy, oversight of clinical trial execution and delivery of multiple programs within the MS, Neurology and Immune Diseases portfolio both Early Phase and Late Phase. Ensured clinical studies adhere to timeline and budget parameters, SOPs, regulatory criteria, ICH/GCP guidelines, and TA strategies and goals. Provide Strategic and Therapeutic Leadership to various functions within operations. Represent the Global Clinical Operations dept at internal and external meetings, including but not limited to regulatory agencies like the FDA and internal R&D Leadership Meetings for the Therapeutic Area (MS,Neurology and IMD). Build relationships with Key Scientific Leaders. Responsible for managing a department of 35 people consisting of Clinical Program Team Leaders, Clinical Project Managers, CRAs, Vendor Managers and CTAs.

Managed clinical development planning and operations for multiple compounds in Multiple Sclerosis. Ensured that all studies within the program were completed on time within budget and in compliance with SOPs, Regulatory regulations and ICH/GCP guidelines and in alignment with Therapeutic Area strategies and goals. Worked with Medical Directors to implement and execute Clinical Development Plans. Responsible for leading the Clinical Development Team (CDT). Utilized operational expertise, knowledge of TA strategy and TA scientific input when planning program feasibility, developing strategies for country selections, CRO/ vendors use and evaluations and planning for contingencies. Presented program status to partners (Abbott) and Neurology R&D Leadership. Managed Clinical Trial Managers working in Neurology. Represented Clinical Operations in multiple Regulatory Inspections.

-Developed short-term and long-term strategic outsourcing plans for data management services that support the business needs of the Therapeutic Areas and Strategic Business Units.-Forecasted and managed functional sourcing budget for offshored projects.-Oversaw offshoring vendor performance across all studies.-Developed a governance strategy to resolve financial or operational issues, which impact timelines, budgets, contracts, deliverables, relationships, etc.-Developed and coordinated offshore vendor training and compliance activities.-Coordinated internal support services required to support offshore data management functional service providers, i.e., IT, Contracts, Legal, etc.-Subject matter expert in outsourcing/offshoring, developing innovative sourcing models, and advising senior management regarding sourcing strategies and trends in the biotech/pharmaceutical industry.-Managed staff in the US and UK

Responsible for clinical project management of phase II trials in Multiple Sclerosis. Conducted site feasibility, selected CRO vendor, worked closely with sites, addressed ethics and regulatory questions and setup infrastructure with external vendors (labs, IVRS etc.).

Responsible for oversight of drug program within Data Management Organization. Played a key role in the successful Data Management activites required for the Tysabri filing. I also participated in other filing activities required from the Data Management group.