Rebecca Lee

1. Develops full life cycle plans to execute overall project goals and other project-related activities with CMC team 2. Create and Maintain detailed timelines independently for campaigns needed to execute team strategy 3. Identified and communicates key project issues/concerns cross functionally and outside parties to ensure all parties are on same page to avoid miscommunication. 4. Create and maintain Project budgeting according to Corporate goal. 5. Track Project deliverables through MS Project, Smartsheet and/or other appropriate tools. 6.Ensure roles and responsibilities are clearly communicated to the applicable and take responsibility for progress or address any concerns from any stakeholders. 7. work with key stakeholders and CMC team for scenario planning to proactively provide analysis and recommendations on alternative development plans, along with associated assumption and risks. 8. Proactively working with outside parties and cross-functionally to ensure the tasks, deliverables and project expectations are well defined, communicated and concerns addressed.

Role: i. Responsible for planning, organizing and overseeing company’s proprietary project to ensure the project is delivered on time, on budget and on scope with up to standard quality. ii. Act as center of communication for internal functional departments and outside stakeholders/partners to ensure the information are aligned. Planning and Communication: i. Work with management team and project team at early stage for development of project strategy, include set project goal and reliable time schedule, are delivered and executed accordingly. ii. Communicate cross functional department to ensure the project plan and any change in plan are fully received and understood by the project team. Driving/Development: i. Coordinate with outsourced service providers, such as regulatory consultant, CMO and CRO to ensure the work scopes are rightfully requested and delivered at reasonable cost. Analysis/Risk assessment: 1) i. Perform project based risk analysis on regular basis to identify the potential risks or difficulties that may affect overall project timeline or budget. ii. Discuss with project team for the identified risks and make mitigation plan for the risk. Follow through the plan to ensure it is rightfully executed.

Role in Program Management Acting as an overall coordinator to ensure that project is rightfully delivered within proposed timeline and budget with adequate resources in place. Role: i. To manage and control the project in accordance to the company’s project development strategy. ii. Work across functional department & with different KOLs to oversee the resource allocation, to assess and manage risks, and to control budget thereby meeting project. Planning: i. Work across-functions to ensure the project development strategy, include set project goal and reliable time schedule, are delivered and executed accordingly. Analysis/Risk assessment: i. Resolving cross-function and contracted organizations’ (eg CMO, CRO) requests by ensuring right resource are available when needed. ii. Providing risk assessment to identify the impacts on project timeline and plan. iii. Risk management to ensure mitigation plan are established and followed through Project Resource Coordination: i. Ensuring the internal team member has consensus on the overall project plan ii. Communicating with external service provider teams to ensure the requested service scopes are clear and could be delivered on time under agreed timeline. Project Budget Controlling: i. Coordinating with outsourced service providers, such as regulatory consultant, CMO and CRO to ensure the right works are requested and delivered at reasonable cost and at requested quality.

Role in Portfolio and Strategy Prepare project development roadmap according to the regulatory requirements and corporate planning which serves as critical development path. Product strategy will take in consideration of potential development risks and propose corrective or preventive strategy. Role: i. Analyzing and research for product of interest for development as proposed by RD and/or BD for preclinical, clinical and regulatory requirements for preparation of development strategy. Go/ No-Go decision making role: i. Working cross-function for preparation of product development strategy and present at corporate development evaluation committee for ensuring appropriate resources are sufficiently allocated. ii. Working closely with project managers for project status updates and to ensure the project development is accordance to regulatory requirments. Development strategy development: i. Studying on regulatory requirements on preclinical, clinical studies of product of interests and competitor products analysis to map out the potential project development strategy. Target Product Profile (TPP): i. Preparing and updating of TPP and product development roadmap for future and on-going projects by working with cross function departments.

Role as Associate Researcher i. Developing manufacturing process and analytical methods for solid, liquid dosage form (generic drugs) and responsible for filing for MA to Taiwan FDA. ii. Developed pain management and antibiotic solid dosage (tablets) and iron chelating injection from component analysis to manufacturing process design, development and validation. iii. Analytical methods development and validation for the responsible product according to pharmacopeia and/or manufacturer's specification iv. Troubleshooting for on marketed products including formulation improvement for enhancing the stability of product.

Thesis focused on the establishment of thyroid cancer related gene methlyation gene bank for oncogene and tumor suppressor