Supporting all aspects of Medical Affairs Operations

• Created all startup SOPs and acted as system owner for all systems e.g., IIS, Datavision, Medical information, Within3 etc., Smartsheet, Think-cell.• Led Medical Affairs related strategic plans including LCM and MA plan.• Liaised with clinical and commercial to plan for launch, Ad board and congress activities.• Managed Market Access activities with NICE, MHRA and all submission activities.

• Acted as single point of contact for Medical Affairs for Exa-cel (first gene editing therapy) launch activities.• Supported Brand Medical Team on all aspects of team functioning i.e., IIS, Med Comm, Med Info, Congress Planning, Medical Operations and US and International Medical Affairs.• Liaised with Clinical Operations to ensure P3b4 trials are on time and budget.• Created weekly, monthly, and quarterly dashboard for Medical Leadership Team for all Teams, functions and regions.• Defined roles and responsibilities for Medical Operations Managers.• Represented Medical Affairs by contributing to corporate wide timeline planning repository.

• Evaluated selected and contracted suppliers for day-to-day operations e.g. IT, office banking.• Led meeting and presented in meeting with Venture Capital, Private Equity.• Coordinated with academia to explore potential collaborations.• Registered entities and evaluated accountants and rebate specialists in Australia.• Budgeted for all products scenarios for Drug Delivery platforms.• Created fund raising strategy for Drug Delivery platform.• Liaised with Universities to license novel assets for patent applications.

• Evaluated and collaborated with publications agency and internal stakeholders to create publications plan for Lonsurf.• Conducted an Advisory Board with top 10 medical experts at ASCO GI 2017.• Held Scientific Advisory Panel for mCRC registry.• Launched IIT process and approved 12 IIT programs.• Manage financial budget to 98% target in 2016.• Started 4 HEOR studies and mCRC registry with vendor support.• Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices.• Extensive knowledge of Pharma and FDA guidelines pertinent to interactions with consulting physician, and legal and regulatory environment of pharmaceutical industry.• Manage development of project plans; forecasts and monitors progress of applicable Medical Affairs projects.• Responsible for overall management of Medical Affairs projects, with specific responsibilities coordinating Clinical Operations and Marketing.

• Leading Knowledge Management to ensure consistency in medical and scientific knowledge updates and training• Deploying External Expert (KOL) Engagement for Global Medical Affairs• Supporting Global Brand Team on EE strategies and integrating EE profiles with external vendors• Reduced time to identify existing trends in literature to validate existing strategy• Deployed Veeva capabilities: CRM, CLM, Vault and others

* Lead and supported all planning activities required to meet goals. This includes leading GMA's annual, midterm, and long-term strategic planning, staffing and budget development processes and activities, as well as the department's day-to-day budgetary, financial and resource issues.* Developed and implemented Standards globally for Astellas' Medical Affairs community; this includes processes and standards for Publications, phase 3b/4 studies and data and for global medical strategy for global products pre -- and post launch.* Lead and managed a team of 12 members in GMA operations ranging from Senior Manager to Director.* Provided direction and oversight for efficient and compliant processes, procedures, and systems to support GMA strategic planning, corporate financial reporting, management of grants, and clinical protocol reviews. Ensure continuous improvement and development of GMA operations.* Strategic development, mentoring, and oversight of GMA Operations teams. Assign staff projects and prioritize activities to support GMA objectives.* Represented GMA at stakeholder meetings for ongoing and prospective projects to establish and influenced project outcomes and strategy, as well as directing project tactics and deliverables.* Built and maintained strategic relationships and influence across medical stakeholders in regions and operations groups within Development and Sales and Marketing.* Cultivated collaborations and relationship external organizations to position Astellas as a competitive and responsible world class pharmaceutical company.* Served as secretariat to the Medical Affairs Leadership Team.

Leadership of operational management, identification of constraints and execution of strategic vision to deliver results. Cross-functional representative on senior management quality oversight team, overseeing department operations and performance management across Clinical, Supply Chain Management, Regulatory Affairs and Clinical Data Management. Identified critical metrics for operating dashboard for senior leadership. Departmental budget of $2 million.• Led and executed Amgen Global Development process improvement portfolio of projects resulted in > $20M savings and 4 weeks off critical path.• Launched corporate initiative to change monitoring staff sourcing model to transition 150 staff in 6 months and > $25M in savings.• Deployed Quality Management System with clear roles and responsibilities from Global Business Process Owners across 40 countries to proactively identify compliance and efficiency bottleneck.• Executed Brazil Hub implementation and setup supplier for studies in China.• Managed 15 staff members with promotions to Director level staff.• Leveraged technology for process mapping to dynamically communicate process

• Created data warehouse with external vendors to identify process improvement opportunities.• Created and maintained data dictionary for Development functions• Managed clinical trial posting, clinical results posting and business continuity

Managed projects and established a process improvement culture. Led and managed project teams to improve operational efficiency in supply chain, clinical operations and marketing. Subject matter expertise on Six Sigma methodology and training. Provided executive leaders and project team leads with project update.

Managed projects and established a process improvement culture. Led and managed project teams to improve operational efficiency in supply chain, clinical operations and marketing. Subject matter expertise on Six Sigma methodology and training. Provided executive leaders and project team leads with project update. Established process improvement team in all business functional area. Created business cases, managed portfolio dashboard and reports. Performed data analysis using statistical principles and Minitab. Performed data collection, data analysis, implementation, launch and communication plans.• Led projects to ensure First-Site ready, increase Investigator meeting operational efficiency and portfolio management.• Provided executive leaders and project team leads with project updates. Mentored black belt candidates in Lean Six Sigma tool and template utilization.• Mentored, setup and implemented governance process and defined committee responsibilities.

As a clinical pharmacist, provide expertise in pharmaceutical agent utilization, patient consulting and interaction with integrated healthcare team to provide disease management and monitoring. Subject matter expert to develop software to perform Drug Utilization Review. Created and follow up on Corrective Action Reports• Led Six Sigma initiatives in Drug Utilization Review (DUR) resulted in > $25 million savings. Provided guidance for prescription and image processing.• Conducted train-the-trainer classes for six prescription processing centers nationally.