• Senior pharmaceutical industry leader with progressive history of success achieving cost controls through establishment of outsourcing agreements as part of drug development and management efforts.
• Build, manage, and lead development and delivery of procurement management processes. Cultivate relationships with internal and external resources, as well as operating and clinical leaders to achieve commercial success on behalf of Novartis Pharmaceuticals.
• Serve as collaborative partner to business franchises, including adding ongoing value as integrated operational resource. Maintain complete understanding of franchise operations and create alignment between clinical and procurement activities.
Lead and manage global clinical contracting group delivering quality, cost-effective and timely external resources for US-based therapeutic franchises and business units for clinical trails services to include establishment and monitoring of global Phase II-IV studies, data management biostatistics, medical writing, central and reference laboratory services, IRT / IVR, imaging, central cardiac safety services and all other specialty services.
Direct professional efforts of 8 staff supporting 6 therapeutic areas. Maintain accountability for performance results. Manage and report on $500M+ clinical development budget. Develop and implement best-in-class sourcing management processes and techniques.
Highlighted Achievements:
• Served as key point of contact for KPMG conducting audits of supplier contracts. Oversaw audit efforts, worked with category managers and Novartis senior management. − Contributed to efforts that resulted in $2M refund from central labs and $500K from contract research organization (CRO).
• Developed outsourcing strategy in collaboration with category management and led global strategic allocation of services. − Proactively managed contractual relationships and compliance with legal, regulatory and financial standards, including SOX, ICH and GXP.
• Established positive reputation on behalf of global outsourcing management department to rest of organization. Promoted group and worked with external service providers, as well as business development team and project managers to drive understanding of procurement function.
• Created and promoted best practices to ensure global outsourcing management successfully responded to changing needs of customers, including legal, operations and regulatory and finance areas. − Developed and implemented tools and process maps in support of clients’ requirements.
Contributed as key member of CRO management leadership team with authority for identifying and managing departmental issues; provided input and led implementation of strategies to manage activities and allocate work for central labs, cardiac safety and imaging. Oversaw professional and personal development of 3 staff. Promoted environment characterized by open communication and learning.
Highlighted Achievements: • Established master service agreements and negotiated rates to achieve cost savings and strategic benefits.
• Fostered strong business alliances with central laboratory & diagnostic service preferred providers.
• Developed quality standards in collaboration with Novartis resources and negotiated with suppliers to integrate standards into master service agreements and daily operations.
Directed strategic direction of outsourced central laboratory activities for global Clinical Development & Medical Affairs (CD&MA). Maintained comprehensive understanding of business in connection with projects for labs and diagnostics. Addressed outstanding issues and questions, and as result of exceptional process management, assumed newly created position as Section Head, Central Laboratory & Diagnostic Services.
Highlighted Achievements: • Collaborated cross-functionally to coordinate upcoming outsourced opportunities to ensure maximum savings was negotiated for organization.
• Developed and nurtured business relationships with identified central laboratory preferred providers and managed negotiations to improve opportunities for cost savings and benefits of outsourcing.
• Liaised with CRO management group to identify and lead resolution of departmental issues.
Oversaw full lifecycle management of respiratory and cardiovascular assets, including negotiating contract terms and monitoring spending. Drafted and reviewed legal documents, negotiated financial and other terms and executed Global and North American clinical research contracts for Aventis’ service providers within Drug Innovation & Approval (DI&A) from pre-clinical through agency submission. Tracked and managed key performance indicators (KPIs) with preferred providers.
Highlighted Achievements: • Supported clinical teams in study start-up phases of clinical trials. − Negotiated one-shot, master and preferred provider agreements with clinical research organizations to include full-service clinical providers, central laboratory, core diagnostics, interactive voice response systems (IVR) and pharmaceutical development, including manufacturing, packaging and labeling of clinical supplies.
• Assisted in financial audits of new providers. Identified appropriate budget between DI&A controlling and Aventis project teams.
• Contributed as ad-hoc member of DI&A project teams to assist with resolving communication conflicts and relationship issues between Aventis project team and clinical research organization.
Coordinated and negotiated with clinical customers; met delivery of clinical supplies in connection with Phase I-IV projects’ timelines. Ensured compliance with technical standards, cGMP, cGCP, safety and regulatory requirements.
