Lena K - Sr. Analyst at Advanced Technology, Clinical Operations at Edwards Lifesciences

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Lena K Sr. Analyst at Advanced Technology, Clinical Operations at Edwards Lifesciences

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Lena K. stands out as a seasoned Strategic Sourcing and Contracts Negotiation Manager with a robust professional network, evidenced by their 2,121 LinkedIn connections. Their career has blossomed across diverse sectors including management consulting, high-technology, government sector, and within the medical devices and pharmaceutical industries. Possessing a potent blend of skills in legal contract negotiation, business development, competitive analysis, and marketing, Lena is a powerhouse of business acumen. They are adept at navigating compliance challenges and formulating astute business strategies. Backed by an MBA with a focus on healthcare management, Lena excels in driving sales revenue, achieving cost-savings, advocating cost avoidance, improving business processes, integrating AI, ensuring legal compliance, enhancing customer retention, and selecting and nurturing vendors.

Currently holding the position of Sr. Analyst at Edwards Lifesciences in San Francisco, Lena K. has honed their expertise in clinical operations within the medical equipment manufacturing industry. At Edwards Lifesciences, they have managed and negotiated complex contracts for groundbreaking heart therapies, clinical trials, and advanced medical device applications. Their previous tenure includes a role at Google, where they adeptly handled contracts management for an array of cutting-edge products and services, from Android and Nest to Stadia and Waymo, composing an impressive track record of over 200 technology agreements annually.

Lena's former experience comprises a managerial role at Gilead Sciences, where they played a pivotal role in drafting, negotiating, and supervising clinical trial contracts for antiviral and oncological research. Additionally, Lena has brought their specialized skill set to positions at Facebook, where they focused on strategic sourcing for digital marketing, and at Varian Medical Systems, tackling commercial contracts in oncology systems and medical devices. Lena's education credentials, currently pursuing an MS in Psychology with Distinction at the University of Phoenix, and an MBA from Regis University, underscore a commitment to continual professional development and cross-disciplinary expertise.

More about this expert

Full name: Lena K
Location: San Francisco, California, United States
Title: Sr. Analyst at Advanced Technology, Clinical Operations
Company: Edwards Lifesciences
Industry: Medical Equipment Manufacturing
LinkedIn profile: https://www.linkedin.com/in/lk2024/
LinkedIn Connections: 2121
Summary: Experienced Strategic Sourcing Contracts Negotiation Manager with a demonstrated history of working in the management consulting, high-technology, government, medical devices & pharmaceutical industries. Skilled in Legal Contracts Negotiation and Management, Business Development, Competitive Analysis, Marketing, Compliance, and Business Strategy. Strong professional with an MBA degree focused on increasing sales revenue, cost-savings, cost avoidance, business process improvement, AI implementation, legal compliance, customer retention, vendor selection and development of successful business relationships.
Skills: Marketing Business Development

Education

University of Phoenix: Master of Science
Attended in May 2022 - Dec 2023
Field of study: MSPsy with Distinction
Regis University: Master of Business Administration - MBA
Attended in Sep 2002 - May 2004
Field of study: Business Administration emphases in Healthcare Management

Positions

Edwards Lifesciences Hybrid: Sr. Analyst at Advanced Technology, Clinical Operations
Aug 2022 - Jul 2023

Edwards Lifesciences is a medical technology company specializing in artificial heart valves and hemodynamic monitoring. It developed SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. I initiate, manage, redline and negotiate 3rd party complex contracts based on full knowledge of financial, regulatory and clinical trial requirements, including Health Care Provider Services Agreements, Master Services Agreements, Speaking & Training Agreements, Research and Development Feedback Agreements, SOWs, NDAs, Amendments, Program Sponsorships Agreements, and other legal contracts for tissue replacement heart valves repair trials, medical devices with patient biometrics and data collection, and advanced hemodynamic patient monitoring, for the Edwards Lifesciences Advanced Technology Department, innovating the future of structural heart therapies. Negotiate clinical trial budgets with cardiology sites to ensure compliance with company-approved guidelines and alignment with fair market value, utilizing legal-approved budget templates. Analyze need for contract amendments or renewals, evaluate prior terms and conditions, and make recommendations, and negotiate changes within medical devices industry guidelines, federal and state regulations. Collaborate with key legal stakeholders to receive and provide guidance on contracts terms and conditions. Identify risks and communicate with the key stakeholders of the company. Manage contracts administration through corporate-required platforms, ECLM, SharePoint, and department trackers, including status updates, repository maintenance, data input, report generation, and report analysis. Create budget, contracts and letter templates, suggest improvements and changes to contractual terms and conditions associated with contract and budget templates. Provide training to incoming staff on legal contract matters and on EW policies and procedures.
Google Mountain View, California, United States · Hybrid: Global Contracts Management, Sourcing & Contracting Intelligence - Google Devices & Services
Jul 2020 - Jul 2022

Android, Nest, Nest Audio, Pixel, Daydream, Stadia, Google Home, Fitbit, Google Wearables, Waymo, Stargate/Teleportation, VR and AR are my products, for which I draft, manage, negotiate, audit and execute legal agreements for Google devices & services, for product management, hardware operations, sourcing and procurement, for hardware and software engineering services, equipment, hardware, software tools, SaaS, Testing and Certification: bluetooth signal testing, pass/fail feedback, battery lifetime testing, eye retina recognition, fingerprint recognition, voice recognition, etc. Work on SOWs, Amendments, Master Sponsored Research Agreements - MSRAs, collaboration agreements for professional services with PhDs, engineering researchers, postDocs and scientists at national and international testing and research Universities, and global fortune 500-100 Companies. Negotiated 200+ technology agreements annually. Managed RFPs, sent RFQs, attended vendor presentations, participated in vendor selection, rates negotiation, rate cards development and implementation to ensure integrity of the contracting process, IP, CI & PII protection, that quality professional services are provided to Google with cost-savings, cost & risk avoidance, execute agreements in accordance with the industry standards, business, finance, legal compliance, and applicable national and international (GDPR, CCPA, LGPD, Asia Pacific Data Protection Requirements, CFR - Code of Federal Regulation, EPR - Extended Producer Responsibility) privacy laws, privacy & data protection, and other applicable US State and Federal regulations. Consultant.
Gilead Sciences Foster City, California, United States · Hybrid: Manager, Development Business Operations, Clinical Trial Contracts
Dec 2021 - May 2022

Gilead Sciences is a biopharmaceutical company that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19. I am responsible for drafting, negotiation and review of CTAs (Clinical Trial Agreements) for global Phase I-IV clinical investigative viral, Covid, and oncology trials and ancillary site contracts, including both language and budget, the management of Functional Service Providers (FSPs) involved in the contracting process, drafting and negotiation of CDAs (Confidentiality Disclosure Agreements). Ensured Gilead Contract Managers and FSP (functional service providers) complete contracts in an accurate, consistent, and timely manner.
Coordinated with the FSPs, Gilead Clinical Operations and Gilead Legal departments to manage and complete the site contract process throughout study duration. Responded and resolved complex issues associated with domestic and international contracts with support from senior staff and Gilead Legal department. Demonstrated success in working collaboratively with stakeholders and senior Development Business Operations management.
Managed the day-today activities in complex clinical trials contracts (CTAs) and budget negotiation processes. Focused on site clinical trials contracting CTAs, fair market value (FMV) compliance of site contracts, and accountability, as it relates to FSP management and clinical site start-up.
Worked with Functional Service Provider (FSP) to implement Site Contracts CALM Contracts Process to ensure efficient delivery of fully executed contracts.
Evaluated contract and budget changes requested within CTAs, identified business and/or legal risks, managed issues to resolution by proposing and providing alternative solutions to legal or senior management. Identified contractual issues/problems and provided recommendations for solutions. Consultant.
Facebook Menlo Park, California, United States · Remote: Global Strategic Sourcing & Procurement Manager - Digital Marketing
Jun 2020 - Mar 2021

Negotiated, drafted and managed execution of digital media and marketing agency supplier contracts (Master Agreements, SOW, Amendments, music licensing and software licensing agreements, etc.) Maintained accurate and complete contract records, worked with various marketing business groups to simplify processes. Ensured contract and process compliance with internal policies and legal requirements. Executed contracts in accordance with WGA – Writers Guild of America est. 2012 labor union and SAG-AFTRA – the Screen Actors Guild-American Federation of Television and Radio Artists est. 1933 labor union regulations and their financial and legal requirements. Ensured compliance with GDPR, CCPA, LGPD, Asia Pacific Data Protection Requirements, CFR - Code of Federal Regulation, EPR - Extended Producer Responsibility, privacy laws and federal regulations. Ran RFPs, attended vendor presentations, participated in digital marketing service providers vendor selection. Reviewed and benchmarked proposals from suppliers to determine fee competitiveness and acceptable bids. Analyzed spend data in Tableau and Excel and agency proposals to support the development of strategic sourcing strategies and plans. Established procurement performance targets and ensured alignment with the sourcing plans in partnership with Global Sourcing Category Managers. Acted as a cross functional partner across Marketing, Source-to-Pay, Finance and Legal Teams. Consultant via eTeam.
Varian Medical Systems Palo Alto, California, United States · On-site: Global Commercial Operations, Oncology Systems & Medical Devices
Jan 2013 - Jun 2020

Varian Medical Systems is a radiation oncology treatments & software maker of linear accelerators and software for treating cancer with radiotherapy, radiosurgery, proton therapy, and brachytherapy. I negotiated and managed complex commercial contracts for the sale of hardware, software licensing, services, professional services agreements, drafted amendments, addenda, MSAs, contract renewals, letters of termination & legal documents offering Oncology medical devices & software solutions for treating & cancer & treatment analytics, utilizing radiotherapy, radiosurgery, proton therapy & brachytherapy. Negotiated BAAs, SmartDoc, SmartConnect, Velocity, FullScale, Mobius, non-clinical use forms, evaluation agreements, CTAs, GPOs, ePrescribe, Mobile App Services, assignment & delegation Agreements, Insightive Analytics with & without Data Rights, SaaS, Developer Mode Ancillary T&Cs of sale & 3rd party vendor agreements: BrainLab, DrFirst; Worked with CROs, supported sourcing projects, RFPs, bids, SOW's, T&C. Assured compliance with federal, state laws & regulations, Company policies, legal requirements, guidelines, industry laws & standards & HIPAA Regulation & Anti-Kickback & False Claims Act. Trained employees on compliance policies. Completed and notarized vendor certification, credentialing & licenses and compliance forms, provided guidance and legal training to Sales & Services. Responsible for gathering requirements, project implementation & QA transitioning Master Agreements into SFDC from SharePoint, designed legal templates, e-signature via DocuSign/AdobeSign, e-archiving fully-executed agreements in SFDC & SAP. Contributed to implementation, functional testing & AI enhancements of Apttus CLM, designed repositories, collaborated with IT to build custom functionalities in SFDC. Assisted Sales and engaged in effective communication with Sr. VPs, legal, IT, IS, Risk Mgmt, audit, Customers' legal teams to achieve extraordinary results and the mission to end cancer.