Maryanne Santilli
Princeton,NJ
Summary
Dynamic Executive Director with a proven track record at Novo Nordisk, driving operational excellence and strategic leadership in clinical development. Expert in financial management and resource optimization, achieving 20% operational efficiency. Passionate about cross-functional collaboration and team development, consistently delivering innovative solutions to enhance trial planning and execution.
Overview
25
25
years of professional experience
Work History
Executive Director – Operational Excellence & Delivery (OED)
Novo Nordisk
Plainsboro, USA
07.2023 - Current
- Provides strategic vision, expertise, leadership and direction for the Clinical Development Organization (CDO) and the overall CMR function (e.g., provision of trial planning/implementation expertise, health equity initiatives and business development activities)
- Responsible for the strategic & tactical leadership of the OED function across the US as part of CDO), including aspects relevant to clinical strategy and business operations (metrics and capacity management), health equity & diversity, trial planning, clinical supplies, site & patient engagement
- Drives effective organizational alignment to company must-win battles, strategic priorities, strategy development, scorecard management, planning & budgeting, strategic initiatives, and relevant communications
- Serves as Head US Clinical Operations on behalf of VP when relevant and appropriate
- Provides proactive strategic oversight and direction for US Clinical Operations and ensures plans are adjusted as organizational priorities change and are clearly communicated across the company
- Is overall accountable for ensuring optimal resource utilization within the area/development portfolio at all times
- Developed resourcing algorithms for US Clinical Operations to drive 20% operational efficiency in clinical execution
- Designed US clinical KPI and supporting metrics across all TAs to drive operational excellence in startup, recruitment and retention
- Drives innovation in clinical drug development, not only within own area but taking a broad and joint responsibility across projects, e.g., via working groups, cross-project collaboration and other global initiatives.
- In collaboration with other TA heads proactively leads the optimization of processes and drives the architecture and future operating model for Clinical Operations.
Executive Director – Business Operations & Alliance Mgmt
Novo Nordisk
Princeton, USA
06.2022 - 07.2023
- Drives cross functional (ie CMR, Market Access, FBS) financial analysis by Therapeutic Area to ensure accurate and timely reporting and accountability (via Core Medical Team (CMT), Evidence Generation Plan (EGP), Enterprise Strategy and Planning)
- Actively creates and fosters relationships to link internal and external resources. Leads the development of relationships with external customers/partners, including professional associations, HCPS, HCOs, agencies, and vendors
- Guides senior management’s decision making involving critical matters to ensure the integrity and continuity of operations.
- Drives cross functional development/management of contracts & budgets strategies across CMR – including compiling, forecasting, tracking and revising as needed
- Serves as a leader and expert within the team, representing clinical and medical viewpoints and strategies in meetings with senior and executive level collaborative partners. Seen as a key resource with how to escalate problems, provide guidance and complete solutions.
Senior Director – Scientific Alliance Management (SAM)
Novo Nordisk
Princeton, USA
06.2019 - 06.2022
- As part of Leadership, provided long-term vision, oversight and direction for the Scientific Alliance Management teams within Clinical Development, Medical and Regulatory Affairs (CMR).
- Represented Novo Nordisk while interacting with external partners and identifying national and international opportunities for collaboration.
- Responsible for managing internal and external strategic collaborations to optimize alliance performance by building relationships, developing and maintaining strong communication channels; leads negotiations and communicates business direction in area of expertise.
- Provided direction and strategic leadership to staff, including line/business managers, within the Scientific Alliance Management function of CMR Operations.
- Accountable for the development/management of relevant contracts & budgets strategies across CMR – including compiling, forecasting, tracking and revising as needed
- Drove the goal setting, prioritization and tracking across functions within Scientific Alliance Management
- Ensured organizational resources are optimized and prioritized continually
- Maintained knowledge of industry trends and developments to innovate and promote future strategic direction for clinical programs, studies, vendors, systems, and sites
- Coached, developed & engaged staff as required across CMR Scientific Alliance Management by assuring training plans (Functional & project level) are developed and deployed for direct/indirect reports
- Led the clinical finance strategy and tactics to develop, execute and deliver clinical studies/programs on time with a focus on budget, compliance and quality
Director – Clinical Trial Management Finance & Operations
Novo Nordisk
Princeton, USA
10.2017 - 06.2019
- Managed North America Clinical Trial Portfolio (Ph -IV) clinical agreements (~2k+ ) and budget management (~$1B portfolio).
- Led integration for Canada investigator contract and budget management
- Identified and managed $5M+ in cost savings initiatives while ensuring clinical trial operational delivery.
Associate Director, Clinical Trial Management Finance & Operations
Novo Nordisk
Princeton, USA
05.2015 - 10.2017
- Supported clinical trials by providing leadership in financial analysis, management, accountability, and control.
- Ensured accuracy and transparency of budgets and oversees the operations of clinical trial investigator and supplier management.
- Led multiple cross functional relationships and initiatives to ensure effective delivery of all department milestones.
Associate Director, Manager of Global Strategic Accounts
Covance
Princeton, USA
01.2013 - 05.2015
- Supported global strategic alliance by working with internal operations, contract management, pricing, and other functional departments to ensure co-development partner relationships are managed appropriately with business practices as aligned with the partnership.
- Managed $500M Ph II-IV clinical portfolio with the understanding of the contractual assumptions of the MSA and accountable for the financial and milestone deliverables.
- Proactively handled alliance governance issues related to contractual and clinical project matters, internally and externally.
- Served as the primary point of contact between clinical project teams and sponsor to address project financial issues. Ensuring financial transparency between the two organizations while maintaining data consistency and accuracy across financial and operational systems.
- Led multiple cross-functional relationships ensuring project financials stay within budget and adhere to contractual milestones.
- Proactively managed financial and milestone risks though root cause analysis, validation out of scope activities, and coordination of cross functional teams to implement corrective and preventive action plans.
- Responsible for driving consistency in revenue forecasting, milestone tracking, resource management and overall financial, operational and client support.
- Led several business process improvement initiatives and developed solutions for facilitating financial analysis, including the implementation and roll out of an internal effort to improve project profitability.
- Managed a team of analysts, responsible for mentoring and coaching to ensure personal and professional skills are being developed and achieved.
Senior Finance Manager
Covance
01.2011 - 01.2013
- Played an integral role in the development and implementation of a new Project Analytics Tool, analyzing project profitability and key financial drivers to drive a consistent data model throughout the global organization.
- Successfully developed Cost Management training material and presented at several conferences in 2012 presenting to an audience of 100+ including members of senior management as well as our CEO.
- Identified the financial training needs within global operations in an effort to mitigate project write-off and streamline internal processes.
- Developed and led multiple training modules for Global Project Management to manage financial performance of their projects more efficiently.
- Administered the financial migration of multiple business units. Works with senior management and operations in defining processes, tools and applications.
FP&A Manager
Covance
01.2008 - 01.2011
- Provided financial analysis, budgeting and forecasting support, strategic planning, and analysis of performance metrics specific to the growth of the Asia Pacific (APAC) Region.
- Acted as a financial business partner and advisor to the VP of the region by offering support, advice and recommendations on the most effective financial operation of the Region.
- Supported the growth of the APAC region over a 2 year period from a $10M business with ~110ftes to ~$34M business with ~225 ftes throughout 18 countries.
- Responsible for creating, compiling, analyzing, and reporting all the required information and schedules to be submitted for the Region as part of the monthly, quarterly, and annual forecast and budget exercise.
- Identified financial opportunities and/or risks and partnered with operations to develop, plan and execute on the opportunity/mitigate the risk with metrics and deliverables.
- Proven ability to work in a cross-functional, fast-paced environment to lead and drive complex operational initiatives and share best practices with finance counterparts in other regions. Team player with a positive attitude who can work with international teams.
- Developed capital business cases with the assistance of the operations team for the expansion and lease renewal of the APAC region. Successfully received approval of 10 new office locations within the APAC region.
Business Partner
Covance
01.2007 - 01.2008
- Created a global budget for the VP of finance and VP of facilities, administration and purchasing. Itemized direct and indirect global costs by region, country and location.
- Prepared capital retrospectives on prior year(s) capital requests versus actual capital spend. Required extensive audit analysis across all business functions.
- Finance owner to Six Sigma teams in process improvement initiatives and developed finance metrics to measure operational savings.
Senior Financial Analyst
Covance
01.2006 - 01.2007
- Collaborated with the Accounting and Controllership organization to improve the accuracy of month-end close and financial reporting.
- Led and designed automation efforts used by fellow financial analysts for monthly reporting analysis.
- Played an integral role in the development of a global forecasting model to enable more effective budgeting and planning.
- Developed a capital process and manual that has been implemented globally across the business unit to ensure consistency and accuracy among all capital business cases.
Finance Analyst
GE Healthcare
01.2005 - 01.2006
- Assisted in the preparation and completion of annual budgets and quarterly forecasts for Global Discovery Systems.
- Assisted global Transfer Pricing manager by preparing quarterly margin analysis reports of selling entities.
- Setup infrastructure for regional reporting and performed monthly analysis on variances.
- Responsible for monthly and quarterly capital expenditure spend, budget, forecast and meetings. Owned the completion of regional monthly management report containing key business variable trends.
Accounting Manager
Lear & Pannepacker, LLP
01.2001 - 01.2005
- Supervisory skills with a proven ability to coordinate multifaceted activities to analyze problems and implement corrective actions.
- Comprehensive accounting and financial experience including all phases of federal and state tax return preparation and tax compliance, financial statement preparation and not-for-profit auditing.
- Advised clients on effective tax strategies through planning and analysis of new tax laws and proposed legislation in an effort to minimize corporate and individual tax liabilities.
- Performed client financial planning using trend analysis by reviewing costs, revenues, and financial commitments to forecast future revenues and expenses.
- Developed business plans, profitability studies, cost analyses, and cash-flow projections to assist business owners with making smart financial business decisions.
- Assisted clients with the implementation & maintenance of an internal control system for supporting compliance and safeguarding the organization's assets.
Education
MAcc - Accounting
Rider University
01.2004
BS - Corporate Accounting
The Richard Stockton College of New Jersey
01.2002
Skills
- Strategic leadership
- Clinical operations
- Enterprise mindset
- Financial management
- Project management
- Resource optimization
- Cross-functional collaboration
- Trial planning
- Budget forecasting
- Team leadership, training, and development
- Develop & execute solutions
Accomplishments
CMR Leadership Award - 2024 For Financial Excellence in Clinical Trials
Timeline
Executive Director – Operational Excellence & Delivery (OED)
Novo Nordisk
07.2023 - Current
Executive Director – Business Operations & Alliance Mgmt
Novo Nordisk
06.2022 - 07.2023
Senior Director – Scientific Alliance Management (SAM)
Novo Nordisk
06.2019 - 06.2022
Director – Clinical Trial Management Finance & Operations
Novo Nordisk
10.2017 - 06.2019
Associate Director, Clinical Trial Management Finance & Operations
Novo Nordisk
05.2015 - 10.2017
Associate Director, Manager of Global Strategic Accounts
Covance
01.2013 - 05.2015
Senior Finance Manager
Covance
01.2011 - 01.2013
FP&A Manager
Covance
01.2008 - 01.2011
Business Partner
Covance
01.2007 - 01.2008
Senior Financial Analyst
Covance
01.2006 - 01.2007
Finance Analyst
GE Healthcare
01.2005 - 01.2006
Accounting Manager
Lear & Pannepacker, LLP
01.2001 - 01.2005
MAcc - Accounting
Rider University
BS - Corporate Accounting
The Richard Stockton College of New Jersey