Clinical Research Supply Chain

DAWN TOI ELLIOTT

346-***-**** *******@*****.*** https://www.linkedin.com/in/toielliott/

TRADE DISTRIBUTION AND CONTRACTS LEGAL PROFESSIONAL Negotiation Issue Resolution Litigation Trusted Advisor Project Management Contract Management Pharmaceutical/Biotech SME in DSCSA Enhanced Regulations Clinical Research Product Launches Process Improvements Technology Implementations OBJECTIVE: Seeking a role that leverages diverse expertise in trade and distribution, market access, contract management, supply chain, CLM deployment and product launch initiatives through fostering a transfer of knowledge and mentoring others. With a deep understanding of industry dynamics will support an organization’s distribution, financial and market access objectives by contributing to its development and implementation of channel strategies, contracting, and pricing initiatives to meet patient needs and access to medicines. HIGHLIGHTS

• 20+ years Contract Strategy Development, Process Improvement, Lifecycle Management of Complex Distribution Agreements with Wholesalers, Distributors, Specialty Pharmacies and Vendors

• Developed Templates, Drafted and Negotiated Complex Wholesaler, Distributor and Specialty Pharmacy Purchase, Services and Data Agreements for launch readiness of cross-portfolio of Therapeutic Areas, to include HCV, HIV, PBC, Antiviral and Oncology

• Successfully negotiated complex financial agreements and executed standardized Wholesale Distributor/GPO/CRO/Clinical Research/Vendor contracts resulting in efficiencies and cost savings

• Developed and Implemented Automated Contract Lifecyle Management (CLM) resulting in cost saving >$3M annually

• Streamlined Contract Reviews, Approvals and Implemented Controls for SOX Compliance and Audit Readiness

• Managed Internal Contracting Team, Contractors and Vendors reducing Expenditures by >$5M annually

• Managed Risk and Implemented Risk Reduction SOPs to align with memorialized financial terms of contracts

• Business Lead and SME for Commercial Organization Governance Committees for Salesforce Platform

• Strategized with Executive Leadership, Finance Controllership, Legal Teams, IT and Internal Stakeholders to Implement a 3-5-year Technology Roadmap to support OTC and financial services reconciliation

• Developed Templates for Wholesalers, Distributors and Specialty Pharmacies for New Product Launches/Network Expansions, creating Efficiencies and Alignment with Industry Trends/Evolving Regulations

• Supported Contracting and made Recommendations for appropriate Contracting Structure for Customer Mergers, Acquisitions and sunsetting of Mature Products

• As Member of Anti-Counterfeiting Team ensured appropriate language incorporated into Contracts to support a Safe and Secure Supply Chain

• Business Lead for DSCSA Nov. 27, 2023 Serialization and Traceability readiness in collaboration with Global Serialization, Trade Operations and Anti Counterfeit legal teams to develop Data Interoperability Agreement terms

• Awards and Recognition: Values at Work Awards for Excellence and Collaboration 2018 – 2024 and Recipient of Technology Innovation Award in 2020

KEY SKILLS

• Project Management and Channel Recommendations for Launch Readiness of FDA Approved Products

• Drafting, Redline Reviews and Recommendations to Minimize Risk Page 2 of 3

• Diverse Contracting, Legal, Regulatory and Compliance Background

• Litigation in State, Federal and Appellate Courts

• Document Management, Drafting Legal Documents, Contracts, Demand Letters, Commercial Distribution Contracts, IRB and Informed Consent Document reviews for Clinical Research Trials, CRO/Clinical Research and GPO Contracts

• Experience in Grant Funding/Contract Negotiations for Clinical Research Trials

• Working knowledge of Federal Anti-kickback Statutes; State drug product dispensing, pharmacy practice and consumer protection laws; Health Insurance Portability and Accountability (HIPAA); Drug Supply Chain Security Act (DSCSA); State pedigree laws; and the Foreign Corrupt Practices Act of 1977; PhRMA Code; OIG, EMA, ICH and FDA Guidelines

• Drafting SOPs/Processes, Development of Training Modules, Implementation of SOX controls, and Creation of Playbooks

• Legal and Healthcare Experience with Research, Analytical, and Negotiation Skills in Pharmaceutical and Biotech

• SME In Contract Lifecycle Management Technology and Process Improvements

• Proven Relationship Management and Leadership Qualities with ability to work independently in a Fast Paced, Heavily Regulated Industry in a Cross-Functional Matrixed Environment EDUCATION

• Johns Hopkins University Regulatory Sciences (General Studies) Baltimore Maryland

• Loyola Chicago University Health Law – Master of Jurisprudence (MJ)

• University of Phoenix BSHM & AAHM

• Washington School of Business Paralegal Studies

• University of North Texas Marketing

EXPERIENCE

Gilead Sciences, Inc. Director, Trade Operations (Contracts Management) 2018 – 2024

• In-house Director of Contracts for biotech manufacturing company

• Responsible for development of a contracting infrastructure within Managed Markets Operations with oversight of Trade Contract Management team, negotiations, and channel strategy recommendations

• Developed templates, drafted and negotiated complex channel and distribution contracts for Wholesaler, Specialty Distribution and Specialty Pharmacy dispensers for new product launches and network expansions. Directly managed negotiations with the Big 3 Wholesalers for organization’s full-line agreements for 97% of company annual sales and internal point of contact for contract terms and issue resolutions

• Managed state licensing function and oversight of licensing vendors to ensure the appropriate licenses in place for distribution of products in collaboration with legal and Trade operations teams

• Established and implemented contracting CLM efficiencies, establishing KPIs and SLAs for contracting lifecycle, and performed GAP analysis assessments of industry trends and market dynamics that impact contracting strategies

• Successfully led the organizational implementation and deployment of end-to-end APTTUS CPQ and CLM platform in 2020 resulting in a streamlined process for contracting, approvals and audit reporting for Managed Market Access and Trade contracting

• Member of Anti-Counterfeiting Team industry working groups to ensure appropriate language incorporated into Contracts to support a Safe and Secure Supply Chain and support investigations as needed Page 3 of 3

• Business Lead for DSCSA Nov. 27, 2023 Serialization and Traceability readiness in collaboration with Global Serialization, Trade Operations and Anti Counterfeit legal teams to develop Data Interoperability Agreement terms for data exchanges and exceptions

McKesson Specialty Health Director, Contracts Administration 2015 – 2018

• Responsible for oversight of day-to-day activities of contract administration team, deal development recommendations

• Developed and maintained contracts management infrastructure in support of specialty provider-facing contracts, and GPOs for the Oncology and Multispecialty Open Market businesses

• Monitored external and internal contract compliance post contract execution through termination. Business Lead for contracting framework and templates in collaboration with specialty law department

• Participated in cross-organizational requirements gathering, vendor selections, and preliminary roadmap for implementation of Contract Lifecyle Management (CLM) platform McKesson Specialty Health/US Oncology Research Contracts Manager 2007 – 2015

• Non-attorney member of specialty law department; Responsibilities included contract negotiations, research, and drafting of contracts in support of SMO clinical research projects, GPO rebate agreements, and Vendor Agreements

• Collaborations with physician practices, academic institutions and CROs on special clinical trial and project agreements

• Assisted business operations and development teams to assess best approach to contract

• Aligned contract terms to organizational objectives while mitigating risk to the organization, network physicians and maintaining patient access and safety

• Identified opportunities within the law department to streamline contract review processes, establish metrics, and successfully developed and implemented a tracking process utilizing Lean Six Sigma concepts PRIOR EXPERIENCE

• Project Coordinator Encysive Pharmaceuticals Houston, TX 2006 – 2007

• Roberts Markell Guerry, LLC Houston, Texas 2005 - 2006

• Sher Garner Cahill Richter Klein Hilbert Sr. Litigation Paralegal New Orleans, LA 2004 – 2005

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