Boston, Massachusetts, United States
· Biopharmaceutical executive with leadership across external manufacturing, strategic alliances, contracting, and cross-functional operations · Track record of strengthening partner performance, governance, and risk-based decision-making across development and commercial environments · Juris Doctor with graduate degrees in biotechnology and business administration; CSAP and PMP certified · Massachusetts Bar member with a strong foundation in compliance, negotiation, and strategic execution
• Lead external manufacturing across a global network of strategic partners and critical materials suppliers, strengthening supply continuity and operational resilience • Own external supply budgets supporting development, lifecycle management, commercial operations, and growth priorities • Serve as Takeda’s senior executive interface with strategic partners, elevating governance, performance expectations, and continuous improvement agendas • Direct cross-functional execution with external partners to resolve issues, reduce operational risk, and improve network performance • Build organizational capability by coaching teams on partnership governance, escalation, and day-to-day external manufacturing operations • Lead partner assessment and diligence to support network strategy, business continuity, and long-term supply flexibility
• Led strategic partner engagement and designed governance models that improved alliance effectiveness, accountability, and decision-making • Oversaw the global contract management team and strengthened operational discipline across complex partner agreements • Identified and advanced opportunities to expand critical external relationships with industry and government stakeholders • Established governance, escalation, communication, and continuous improvement mechanisms that increased collaboration effectiveness across strategic partnerships • Coached cross-functional teams managing strategic partnerships and embedded best practices across adjacent functions • Supported business development through partner assessment, diligence, and strategic evaluation of new opportunities • Ensured compliance with internal policies and regulatory requirements while reinforcing inspection readiness • Helped shape a high-accountability culture aligned to enterprise priorities, collaboration, and execution excellence
• Led high impact projects and cross functional teams to advance our internal pipeline to registration, support securing new assets, establish strategic collaborations with partners and support life cycle management activities • Developed integrated project plans with partner functions, such as regulatory, quality and clinical which are designed to meet internal (e.g. Quality) and external standards (Global Regulatory) • Served as the single point of contact with strategic partners and managed these collaborations • Established and managed the process for the collection, synthesis and dissemination of information internally and with strategic partners • Ensured the integration of internal work streams and external objectives/deliverables • Identified and leveraged partner strengths to maximize the value of collaborations • Translated complex global activities into working processes for regional contributors to global programs; assessed process gaps across regions for global programs • Led the strategic definition, creation, documentation and maintenance of project management standards, processes and tools and developed and promoted the use of PMO best practices across the organization • Ensured that tactical execution and related budget plans were developed and maintained, and that information was effectively utilized by the leadership team • Identified issues and obstacles that could impact the timely completion of deliverables and resolved them with team members and/or the relevant functional management
• Managed the organization to ensure appropriate assignment of SOW tasks, responsibilities and authority levels • Participated in Business Development opportunities by identifying opportunities, engaging partners and leading the development of strategies and the compilation of costs • Negotiated contractual terms, conditions and financial terms of subcontractor agreements • Prepared and managed the administration of domestic and international contracts • Developed, prepared and implemented amendments to existing contracts, coordinating with the appropriate stakeholders • Applied earned value management techniques for cost and schedule control • Issued Requests for Proposals to potential subcontractors, evaluated proposals and documented the third party vendor selection process • Analyzed cost variances (forecast vs. actual) and developed recovery plans as necessary to ensure budget goals for the area of responsibility were achieved • Ensured subcontractors are in compliance with acquisition regulations and are providing required deliverables in a timely manner • Provided programmatic updates to both the customer and the executive team • Monitored and documented risks and took action to evaluate, escalate and archive risks as appropriate • Developed spending forecasts for the organization • Ensured that operating procedures were established and compliance was achieved • Planed and de-conflicted resource requirements • Maintained visibility into task performance and accomplishments
• Developed government contracting strategies by identifying and evaluating potential opportunities and recommending next steps to ensure funding for research and stockpile procurement • Served as project manager for pharmaceutical development projects for the Department of Defense and the National Institutes of Health • Led all government contracting initiatives within the Vaccines business including negotiations and proposal development • Ensured all system requirements are in place and updated as needed to adhere to FAR guidelines in conjunction with Finance and Legal • Served as product manager responsible for international sales of a second generation smallpox vaccine • Actively pursued and engaged partners to procure government contracts, in-license vaccine candidates, and share distribution rights including the closure of multiple deals with industry and government partners • Monitored domestic and international government funded vaccine development opportunities and developed relationships with key decision makers for government funding and proposal evaluation • Worked with other business units to identify opportunities and provide guidance for biological research and development funding • Performed competitive market research and analyzed competitive intelligence regarding contract awards, acquisitions, mergers, and licensing agreements in the vaccines industry
• Managed the overall process of planning, scheduling and controlling the project from initiation to project closeout to ensure timely completion including creating, monitoring and closing out integrated timelines • Identified issues and performed solution-seeking analysis, and served as a mentor within the department • Managed budgets and resource expenditures and assisted in the optimization of resource allocation and processes • Coordinated information between departments and linked actions/issues across departments, including integration and assessment of the impact of changes to the timeline • Constructed, adapted, or followed a logical process to assure achievement of project goals and objectives
• Managed nonclinical and Phase I drug development of a biological vaccine product by serving as the integrated product team lead, ensuring subcontractor startup, reviewing proposals, reviewing monthly reports, leading telecons, and presenting updates to senior management • Led the development of proposals and supporting documentation for the Department of Defense and NIAID to procure funding for vaccine development efforts which included acquiring proposals, identifying key personnel, projecting budgets, and presenting all materials per organizational requirements • Assisted in the development of an Investigational New Drug submission by reviewing data, drafting technical sections, gathering references for support, and was the lead in developing several amendments • Managed subcontractor projects for nonclinical testing, the development of monoclonals, assay development, in vitro testing, and process validations • Led the development and implementation of a Vaccine Product Development Plan that road mapped the manufacturing process, product testing, non-clinical studies, clinical trials, and regulatory strategies