CNS TA Lead for Portfolio Strategy & Asset Management

Program Manager for CNS compounds

Managed early and late stage pediatric and adult vaccine development programs and supported departmental improvement initiatives.- Managed global, cross functional, cross divisional teams, including European Joint Venture, for marketed rotavirus vaccine to develop and execute on life cycle management plan, specifically ensuring cross divisional alignment of strategic priorities for expanded capacity projects to meet emerging market demand and timely fulfillment of regulatory requirements.- Managed cross divisional, senior management steering committee to develop and oversee execution of strategy to address evolving global regulatory interactions related to adventitious agent issues. Received Award of Excellence for leadership contributions resulting in on time completion of regulatory inquiries. - Launched and managed early development team for target candidate to support delivery of strategic development plan including assessment and decision on phase I regulatory strategy resulting in three to six month acceleration for planned phase I study start.- Represented Vaccine Project Management group on organizational process improvement initiative to develop new project model in Microsoft Project to support company-wide connectivity objectives, specifically to create foundation to support cultural and process changes needed to improve execution of projects and drive business value- Independently developed and implemented modifications to SharePoint platform for use across all vaccine programs resulting in time savings for Project Managers and ease of use for team members.

Managed development and implementation of CEO mandated Developing World strategy.- Supported Medical Affairs/Policy and Marketing leaders and provided integrated project management of multiple global, cross divisional teams aimed at executing strategy to accelerate access to Merck vaccines in developing countries and eventual integration of developing world activities into functional objectives and budgets. - Developed, tracked and managed detailed product specific project plans, team objectives and performance metrics. Developed and managed annual budget of ~$1.5 million within company guidance of five percent. Utilized Change Execution Management methods to identify high level issues and risks for senior management committees.- Utilized Six Sigma methodologies to develop process to prioritize target markets and set annual and long range cross divisional strategic and operational objectives specifically related to advocacy and external engagement strategy.- Gathered external stakeholder feedback on product image, researched external stakeholders to participate in medical and policy expert input forums and analyzed country specific data to inform external engagement strategy.- Managed collaborations with external global partners (WHO, PATH) on HPV demonstration projects. Recognized with Award of Excellence for contributions leading to on time start of PATH projects.

Supported early and late stage cross functional development teams across vaccine and pharmaceutical therapeutic areas.- Led Submissions Management team responsible for filing worldwide regulatory supplement for marketed HPV vaccine on time to meet divisional scorecard objective. Recognized with Special Achievement Award for outstanding leadership qualities and project management expertise on complex project that was well beyond expectations for individuals at this level. - Managed global filings for two significant manufacturing supplements, with clinical data, for marketed MMR vaccine resulting in timely approvals needed to ensure uninterrupted global supply. Recognized with Award for Excellence for continually demonstrating a keen understanding of the complex issues facing the program.- Managed complex global early stage program with multiple drug products, disease targets, and activities conducted with subsidiary and multiple external partners resulting in company’s first ever filing and approval of submission to FDA Office of Gene Therapy. Recognized with Award for Excellence for exceptional performance resulting in ahead of target start to first in human study.- Key contributor on departmental process improvement initiative aimed at standardizing Project Management processes and tools allowing for more efficient practices resulting in significant value add to Project Teams.

Developed assays and performed clinical sample testing. - Performed ELISPOT assays to monitor immune responses in phase III herpes zoster vaccine clinical trials and worked with clinical staff to ensure timely delivery of results.- Developed and implemented protocols for new assays. - Contributed to scientific strategy of the laboratory and trained new staff.

Studied Mycobacterium tuberculosis in BSL-3 facility and managed laboratory.