Kristen DiCristo

Innovative biopharmaceutical senior leader with targeted experience in strategic partnerships, business development, alliance management, integrations, divestitures, contracts, strategic outsourcing and relationship management as it relates to the R&D functional areas of pharmacovigilance and regulatory affairs and the quality and compliance that are foundational to success. Strong reputation of over 25 years for building and developing long standing relationships while initiating change through influence, partnering, and leading global teams. Co-led the evaluation, strategy and ultimate design of the R&D Operating Model for Organon & Co., the spin-off company of Merck & Co., Inc. At the senior executive level. Contributed to the value determination of Organon as a standalone business including defining the overall strategy, value case, operating model, and investor story. Led identification of operational requirements to enable a spin, the costs & risks those requirements entail, and plans to mitigate such risks. End to end responsibility for business development activities across R&D functional areas globally including pharmacovigilance, labeling, regulatory operations, compliance, regulatory affairs, clinical development and medical affairs. Managed the strategy, due diligence activities, negotiation, and provisions of the R&D functional components of Commercial Agreements with external business development partners involving but not limited to acquisitions, mergers, licensing, collaborations, co-development, distribution, comarketing, copromotion, tech transfer, joint ventures, and divestitures. Post-execution activities include the implementation of obligations across R&D functional areas through the negotiation and execution of ancillary agreements such as PVAs, RAs, etc. As well as transition to business as usual. Drive business process and digital innovation in the business development and alliance management space via development & launch of industry-first system to manage the lifecycle of Business Development activities. Leads information management across R&D functional areas. Provide leadership and direction for the planning and oversight for all outsourced vendor management activities in support of an integrated flexible capacity model across the organization. Leverage relationships with vendors to support business needs & execute on business plans through management expertise to drive operational performance in the supplier management ecosystem, while directing the resolution of highly complex or unusual operational issues.