Manli Chen

● Successful Oversight and Strategic Execution of Multiple Studies - Effectively lead and execute two global trials: Phase II, 4 cohorts, 8 countries, 227 pts & Phase III, 20 countries, 603 pts with advanced knowledge of full cycle study management GCP and therapeutic areas, closely monitoring and mitigating various study risks, strategically collaborating with SMT, regional leads, CRO, and vendors as well as managing related financials and ongoing resource needs to ensure optimal study performances. - Highly proficient with proprietary and industry standard systems and tools to effectively track, oversee, and communicate on critical program statuses to all key stakeholders. ● In-depth Insights of and First-hand Experience with Post-trial Access (PTA) Implementation - Fully utilize extensive PTA expertise to conduct thorough research and analysis on country specific regulations, incorporate trial best practices and external benchmarking metrics to formulate feasible pathways for proper SG supply options for patients, and guide internal and external teams to effectively navigate the process to ensure safe and seamless transition of on-treatment patients to shorten trial closeout timeline. - Actively contribute to ideation of trial closeout process improvement initiatives/departmental SOP development and regularly provide key trial updates and program suggestions to senior leadership members. ● Authentic and Inclusive People Leadership with Empowering Mentorship and Strong Team-building Capabilities - “Shine” awards for “I am bold” & "I own". - “Appreciate” awards for “I care" & "I am bold”. - Established comprehensive plan to coach and manage summer interns on meaningful projects. - Fostered transparent and empowering relationships with direct reports. - Ongoing deep commitment in mentoring junior colleagues from other departments throughout the organization.

o Efficiently spearhead global Gilead sponsored Hepcludex study (11-country, 85 sites, 850 pts) to gain accelerated FDA approval by expediting study startup and CRO onboarding process to shorten study timeline, strategizing effective country-level rollout plans to achieve aggressive response time to FDA, and launching site selection and feasibility effectively with significant CRO cost savings. o Drive Gilead sponsored Purpose 1 and 2 (lenacapavir) as Trial Lead to collect valuable qualitative insights and clinical data to support successful FDA filing, approval, and commercial launch by ensuring clear objectives and directions for all external collaborators and internal stakeholders in G.Ecosystem and adjusting strategies and tactics throughout the program. o Successfully lead program/SOP development and strategic formulation for Gilead’s first Intermediate-size Population Expanded Access Program (ISP-EAP) for oncology TA and guide Named Patient Compassionate Use expansion into EU27 and ACE regions (Team award: 2023 Global Innovation Forum Finalist). o Efficiently manage early phase oncology trial to ensure challenging issues being resolved promptly through thorough investigation of root causes, strong collaboration and partnerships with key stakeholders and CRO/vendors, clear and timely communications, and resourceful/adaptive approach. o Recognized as a Subject Matter Expert and successfully contributed to the satisfactory pass of 2024 FDA Inspection. o Strategize responses to FDA’s inquiries for oncology trials. o Effectively manage CRO/vendor teams and collaborate with cross-functional leads to develop online request portal specs and incorporate regulatory insights to establish 5 comprehensive online portals to streamline processing of increased number of global requests. o Efficiently resolve CRO, HCP, regulatory, and logistics challenges to ensure timely drug supplies to critically ill global cancer patients. o Nominated for 2023 “Career Mentor Star”.

o Drive operational success and strategies of cross-TA Gilead-sponsored (GS) clinical studies and 35+ investigator-sponsored and collaborative studies, ensuring all aspects of clinical trials are conducted within planned timelines and budgets. o Partner closely with CPMs and functional heads to lead collaboration across disciplines ensuring efficient execution of clinical trials, database infrastructure build, data listing review, and timely completion of interim and final CSRs to successfully meet regulatory requirements. o Manage SMT meetings and cross-functional Operations Tracking Meetings with ongoing guidance and oversight of project statuses to proactively identify operational challenges and provide risk mitigation solutions. o Lead cross-functional teams’ initiative to resolve challenging clinical supply issues through establishing strong relationships with key stakeholders and senior vendor leads, accurately identifying root causes, and proposing effective solutions, resulting in a streamlined process that ensures successful clinical supply support for 15 clinical studies with financial impact of $1.5 million. o Train CROs, vendors, study investigators, and staff on GS study requirements. o Active in vendor selection process, RFP review, and contracting negotiation, closely collaborating with vendor outsourcing team (e.g., led vendor negotiation to reduce overall study logistic support costs by 50% for studies across HIV and liver TAs). o Effectively manage CRO vendors and clinical data vendors, ensuring Gilead’s study expectations and timeline. o Communications and Marketing Lead at GAIN (2019 – 2022): Drive GAIN messaging efforts on multiple platforms and play key role in developing a series of online learning seminars and programs for 800+ members. o Lead various departmental team-building events, volunteering service programs, and participate in CTM forum planning and implementation committee.

- Achieved 23% project cost reduction by leading a challenging 15-country global study, making timely strategic adjustments, partnering closely with cross-functional team leads and clinical sites, tactically implementing mitigation steps, and aligning milestone goals among sub-teams with the overall clinical study goal. - Executed the full life cycle of 6 global clinical study enrollment projects, with proactive involvement in clinical strategy, project planning and implementation, investigator/kick-off meetings, clinical site/vendor selection and contracting, data collection and analysis, performance reporting and presentations, budget management and forecasting, to exceed performance goals and consistently deliver timely and quality trial results. - Conducted 10+ global training seminars and educational webinars to ensure key stakeholders’ (e.g., sponsors, CROs, and investigative sites) compliance with FDA/EMA regulations and ICH/GCP guidelines when conducting clinical trial data collection and validation, recruitment performance tracking, and final reporting. - Achieved 20% project management time-saving among PMs by devising process standardization and consolidations for senior leadership and acquiring team leads’ endorsement and implementation, resulting in enhanced operational effectiveness and optimal company profits.

I worked as the Senior Data Integration Manager for BBK Worldwide full-time through July 2015 due to family relocation to Silicon Valley and continue to work as a remote senior project consultant on a project basis.

- Managed global clinical trial projects of various phases in a deadline driven, fast-paced environment, collaborating with study sponsors and/or CROs to determine protocol requirements, key performance indicators, project milestones and critical paths, reviewing solutions for potential challenges, and building solid IT infrastructure to ensure efficient project deployment and completion on time and within budget. - Achieved global trial success by developing effective trial plans, executing metric-based clinical site/SP selections and RFPs, ensuring key stakeholders’ (e.g., sponsors, CROs, investigative sites, and data processing team) compliance with ICH guidelines and FDA regulations when conducting clinical trial data collection, validation and import, conducting regular recruitment performance tracking, deploying clinical trial management best practices, and providing responsive trial consultation, technical support, and training seminars. - Successfully collaborated with various third party vendors to implement clinical system integration and to innovate clinical trial productivity enhancement products including global trial reimbursement programs, multi-country SMS trial visit reminder services, trial participant engagement mobile applications, and clinical study e-binders. - Significantly increased global user adoption of cloud-based clinical data management system from international user base by hosting worldwide training and educational webinars, conducting user research and system performance evaluation to enhance feature quality, and providing responsive technical and admin assistance to end users from 30+ countries. - Strengthened business relationships with Fortune 100 clients to achieve high retention rates and follow-on project awards, and expanded new client base by analyzing target market dynamics, identifying future trends in demand and unmet client needs in various global markets, generating effective marketing strategies.

- Reached project goals three months ahead of allotted timeline by efficiently managing multi-country project critical paths, launching effective multi-channel marketing campaigns using marketing automation tool, navigating ambiguity with sound judgment, and making decisive strategic adjustments based on real-time data analysis and situational evaluation. - Managed large-scale international projects overseeing all aspects of development from conception to closure with highly detail-oriented approach and efficient resource allocation, timely communications of project updates and potential risks with stakeholders and business partners, and presentation of actionable solutions for global executive team members. - Collaborated closely with cross-functional teams including client services, creative group, and engineering team to promptly resolve project challenges, and managed global business partners and media agencies to build solid foundation for healthy long-term relationships and profitable growth. - Led clinical trial best practices and study site engagement initiatives across 20+ studies, collaborating with clinical operations and IT teams to develop effective infrastructure and content to reinforce best practices in the areas of trial recruitment, referral processing, data entries, patient interactions, and regulatory compliance to significantly enhance trial performance and patient satisfaction. - Generated 100+ actionable leads and expanded new market reach by attending international conferences/networking events and establishing new strategic alliance partners in Asia, Europe, and Africa. - Grew global vendor and alliance partner network by 50% through proprietary assessment metrics to evaluate vendor/partner capabilities, operational efficiency, strategic profile, and compatibility, building solid foundation for long-term collaboration and profitable growth.

- Accelerated new market entries successfully by spearheading global R&D projects and efficiently managing research vendors to provide comprehensive key insights into more than 30 countries’ business landscapes including industry regulations, infrastructures, challenges, opportunities, and crucial target population profiles. - Developed 50+ comprehensive surveys (global feasibility, country/site selection, pre-qualification surveys), collected primary and secondary data, conducted in-depth interviews and focus groups, and generated impactful research reports and solutions for Global Research Division, significantly increasing success rate of new country penetration and target customer reach. - Enhanced team productivity in the Global Research Division by implementing adaptive research guidelines and encouraging team members’ inputs to enable project completions ahead of deadlines.

- Provided assessment and feedback of the effectiveness of application designs/content and ad messaging to ensure successful deployment of application products and online advertising on Google platforms.

RENSSELAER POLYTECHNIC INSTITUTE, Lally School of Management & Technology, Troy, NY May, 2008 Research Fellow, Innovation Management / New Product Development / Marketing Research Fellow, Entrepreneurship - Provided indispensable research support for a published research project studying the impact of social networks and interpersonal skills on entrepreneurs'​ business performance and their ability to obtain financing. - Analyzed syndicated data and presented research findings and made recommendations at national and international conferences, receiving Best Paper Awards. - Developed new research ideas, managed multiple projects simultaneously including designing surveys, conducting in-depth interviews, collecting primary and secondary data, and generating peer reviews. Teaching Assistant, Marketing Strategy/ New Product Design/Consumer Behavior - Prepared lecture and academic materials, developed college-level examinations, and evaluated 100+ college students' academic performance. - Taught both MBA and undergraduate courses including “Consumer Behavior”, “Product Design & Creating”, and “Managing an Enterprise”.

- Increased revenue in designated facilities by 12% within first six months by conducting thorough market research, analyzing market feasibility and profitability, and devising and implementing effective marketing campaigns. - Expanded new customer base by 20% through onsite visits and incentive programs. - Utilized advanced tracking tools and forecasting software to generate market insights to achieve long-term growth.

- Provided essential support to Division Manager in monitoring and tracking a team of 20+ financial advisers’ daily performance and productivity. - Managed a large client database of 5,000+ portfolios and developed creative business plans to enhance client participation and investments. - Designed comprehensive marketing plans for Online Investment Services team to effectively target local colleges.

- Played a key role in research support, staff assistance, trouble shooting and customer service in various departments on campus as well as made recommendations to improve student overall programs and services.

- Conducted extensive market research and developed sales strategies and reports for senior management in Shanghai Headquarters, generating 30+ actionable leads. - Supervised a team of 20 sales representatives and administrative assistants and provided solutions to increase productivity.

- Developed engaging tour plans for domestic and international tour groups and led the groups to various destinations

PhD. Candidate, Dean’s Merit Scholarship Concentration: New Product/Service Development, Innovation Management, and Cross-cultural Consumer Behaviors - Vice President of Student Affairs & Public Relations, Chinese Student & Scholar Association - Doctoral Student Committee Representative - Executive Assistant to the Presidential Candidate at New York Capital Region Chinese Community Center (CCC)

MBA, Dean’s Merit Scholarship - Simmons Finance Club - Simmons Consulting Group - Organizer of the Annual Women’s Leadership Conference

BA, Business Administration, Major: Marketing Cum Laude - Simmons Academic Scholarship - Dean’s Lists for all semesters - Elected Simmons College Ambassador

AD, Applied English; Minor: International Business - Secretary General of Youth League - Student Education Minister of the Department - President, Badminton Club