Executive Team member reporting to the CEO. Responsibilities include the Regulatory Affairs, Quality Assurance, Pharmacovigilance, and Medical Writing functions.

Cubist Pharmaceuticals acquired by Merck & Co, Inc. January 2015

Product Development and Lifecycle Management• Global Regulatory Lead for ZERBAXA® (ceftolozane/tazobactam) Product Development team responsible for Major Market (US, Canada, Europe, Australia/NZ, Japan) and Rest of World approvals and lifecycle development including indication expansion.• Regulatory therapeutic area lead responsible for teams managing lifecycle development of DIFICID® (fidaxomicin) and other drug candidates from Phase 1-3.• Supervisory responsibilities for CUBICIN® (daptomycin) global pediatric lifecycle studies.Corporate Direction and Expansion• Develop and present critical program strategies to the executive team (e.g. CEO, COO, CMO, CSO) and other key stakeholders and provide timely updates on the status of critical regulatory milestones to inform corporate direction. • Provide strategic insight when evaluating potential assets for business development opportunities. • Represent the company at industry-led initiatives such as PhRMA Limited Duration Key Issue Teams. Portfolio Strategy and Planning• Advise teams and champion the development of innovative strategies for the acute-care franchise from preclinical through post-marketing stages. • Guide the development of meetings with global regulators and lead negotiations in support of submission and approval of flagship products.• Identify and engages key internal and external collaborators to address potential impediments such as regulatory policy shifts, data-driven obstacles, and difficult team dynamics.Functional Growth and Compliance• Develop staff capabilities to plan international marketing applications, develop harmonized global strategies, and build effective relationships with regulators. • Construct a dedicated and scalable function within regulatory affairs responsible for all multinational CTAs across the portfolio to meet corporate growth objectives. • Integrate programs added through M&A into the function and effectively balances workload across the team.

Asset Strategy• Regulatory leader responsible for the hepatitis C portfolio strategy including INCIVEK®/INCIVO® (telaprevir) regulatory interactions, rapid response, and label negotiation teams. • Core member of the sponsor team at the FDA Antiviral Advisory Committee Meeting (28 April 2011).• Lead Regulatory representative on inter-company teams with three development partners from Europe, the US, and Japan.Functional Leadership• Responsible for guidance and oversight of Regulatory Liaisons managing influenza and epilepsy portfolios. • Set goals, provide leadership development and professional growth opportunities to staff.• Advise cystic fibrosis regulatory team regarding KALYDECO® (ivacaftor) marketing application strategy.Competitive Intelligence and Regulatory Policy• Project regulatory pathways for competitor programs pre- and post- major congresses as a member the CI rapid response team. • Panelist and member of HCV Drug Development Advisory Group (HCV-DrAG), a cross section of industry, academia, and global regulators who meet regularly to address the emerging issues of developing new compounds to treat chronic hepatitis C.

NDA/MAA Preparation and Planning• Member of the TYZEKA®/SEBIVO®(telbivudine) label negotiations team; responsible for rapid response to questions from US, Europe, China, Australia, Canada, and ROW applications.• Provide regulatory input to the project team to ensure compliance with FDA, EMA, and ICH guidelines. • Manage a publishing and QC team prior to final in-house compilation using eCTDXPress and submission to FDA via the electronic submissions gateway.Development Stage Management• Responsible for exploratory INDs (“Phase 0”) used to select a lead candidates based on the evaluation of a microdose of investigational compounds.• Plan and execute INDs in eCTD format that included reviewing and authoring sections of the dossier. • Supervise and mentor associate responsible for ex-US clinical trial submissions.Corporate Partnerships• Active participant in joint development meetings with partner (Novartis). • Ensure that questions from the partner’s affiliates were tracked and answered in a timely fashion.

Development Project Management• Responsible for regulatory compliance and submissions supporting development of the IMOJEV® (Japanese encephalitis), CYD-TDV, West Nile and CDAD toxoid vaccine programs.Chemistry, Manufacturing, and Controls (CMC) Submissions Management• Prepared and submitted major CMC submissions detailing complete reformulation of vaccine candidate used in Phase 3 trials and for subsequent licensure.Clinical Regulatory Oversight• Participated as lead regulatory representative during successful meetings with the TGA in Australia and BGTD in Canada.• Worked directly with chief scientific officer, director of pharmacovigilance, and clinical group to resolve clinical hold issue affecting critical vaccine project (see Johnson et al in Patents, Publications, and Presentations).Research Associate III ChimeriVax™-West Nile and -Dengue Vaccine Project • Performed extensive Biosafety Level 3 work designing, constructing, and testing multiple attenuated chimeric vaccine candidates.• Designed strategy for creating attenuated chimeric West Nile Vaccine in BL-3 facility at CDC (Fort Collins, CO).• Wrote technical reports and CMC information to support IND submission; designed and constructed chimeric viruses consisting of the structural genes of four Dengue serotypes fused to the Yellow Fever (YF17D) vaccine non-structural region; trained new scientists and colleagues to use the ChimeriVax™ platform technology. Helicobacter pylori Vaccine Project • Cloned, expressed, and purified recombinant proteins from H. pylori in E. coli.• Created economical bioinformatics systems genome analyses.