Associate Director, Site Contracts & Budget Management, Financial Transparency Oversight

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

The Site Contracts and Budgets Management (SCBM) group, in Global Clinical Operations (GCO), develops strategy and provides oversight to all studies in compliance with internal processes and external requirements for the following areas in the study start up space: site contracts, budgets, site payment and related reporting including global clinical trial financial transparency and Medicare, Medicaid, and SCHIP Extension Act (MMSEA) reporting for US sites.

Included in the remit of the SCBM group are activities to support GCO's compliance with DSI financial policies, investigator fee budget creation and review, oversight of the site budget negotiation process, FMV review, Global financial transparency reporting (Sunshine and EFPIA), MMSEA reporting and timely payments to clinical sites.

The current process is supported by CRO partners with which the SCBM group collaborates and provides oversight of outsourced or contracted activities utilizing both performance and quality measurements.

The Associate Director, SCBM Financial Reporting & Strategy position provides leadership in strategy and process development for Global Clinical Operations (GCO) to ensure the implementation of best practices in the timely and efficient administration of site budget financial operations and payments and compliance with US and Global reporting requirements. As GCO's Subject Matter Expert (SME) for the site budget, payment, reporting and financial transparency processes, the role identifies process improvements, participates in governance activities and CRO relationship management and liaises with internal/external stakeholders on cross-functional initiatives.

The Associate Director, SCBM Financial Reporting & Strategy's responsibilities include the management of employee direct reports and the functional management of FSP analysts.

Business needs within the group may require this role to take on an increased focus on one or more of the above areas or even additional related areas to ensure Global Clinical Operations (GCO) goals are met.

Responsibilities:

Investigator Grants / Site Budget Financial Reporting Strategy

• Provide guidance and strategic planning in connection with the reporting of financial transfers and payments in the conduct of clinical trials in accordance with applicable laws and regulations including the Sunshine Act and MMSEA in the US and global financial transparency laws.

• Provide functional input to develop better defined process flows, roles and responsibilities and communication pathways to ensure compliance with financial reporting policies and laws.

• Liaise with Legal, Compliance and Finance on company positions on legal developments, financial policies and regulatory guidance pertaining to site financial reporting, FMV, financial transparency and site payments.

• Collaborate with the appropriate stakeholders within and outside of GCO including but not limited to GCO Leadership, GCO Study Management, CROs, Procurement, Legal, Compliance, Finance, Clinical Development, Global Project Management, and Functional Quality groups, to ensure GCO's reporting processes and expectations are mutually well understood and executed.

• Develop and support sound process and policy in GCO Financial Transparency (FT) reporting.

• Identify trends, innovations and opportunities to ensure adherence to best practices.

• Lead GCO process improvement initiatives for the global reporting of GCO clinical trial spend.

Financial Transparency (FT) and MMSEA Reporting Compliance

• Provide subject matter expertise in the implementation of transparency and reporting processes for GCO managed clinical trials.

• Accountability for the coordination and oversight of GCO's financial reporting process with external GCO FT vendors.

• Oversee the GCO Financial Transparency/MMSEA team's review and reporting responsibilities.

• Manage GCO's issues, risks and challenges in the reporting process.

• Oversee the implementation of improvements to process, data collection and analysis and identification of reporting gaps.

• Respond to internal questions regarding GCO FT compliance.

• Support annual GCO FT reporting.

• Collaborate with the development of metrics and tools to support reporting compliance.

• Report on GCO compliance with global reporting requirements to GCO leadership.

Investigator Grant/Site Budget Administration Strategy

• Provide global strategic investigator grant planning specific to program and study needs for site budgets.

• Collaborate with relevant stakeholders (Finance, Procurement, Compliance, GCO operations) to establish a portfolio level site budget strategy.

• Develop and continually enhance a robust site budget development strategy and ensure consistency across the portfolio.

• Monitor trends, industry best practices, refine existing guidance and tools.

• Develop country specific site budget strategy to align with applicable country requirements, laws and practices.

• Provide expert guidance on the standards and areas of internal and external compliance and financial responsibility.

• Provide study specific site budget financial review and analysis.

• Provide routine and ad hoc updates and analysis on site budget performance.

• Develop financial analytics and financial predictive tools to support Investigator grant planning and execution.

• Collaborate with external stakeholders on the content and cadence of performance reporting from CROs and other vendors.

• Lead GCO process improvement efforts in the administration of investigator grant/site budgets.

Site Payment Administration

• Oversee the global site payment processes by payment vendors.

• Review and align on payment vendor policies and procedures.

• Implementation of site payment processes and technology to optimize timeliness and accuracy of payments.

• Oversee the global site payment reporting processes.

• Oversee the implementation of travel vendor services.

• Serve as an operational escalation point for trends and issues.

• Provide guidance and support to the study teams when needed to ensure timely and compliant documentation of payments.

• Oversee and managing issues and risks for individual studies by addressing investigator grant budget challenges.

• Implement processes for the tracking of spend v budget.

• Oversee and support the financial reconciliation process for site budgets.

• Respond to CRO queries on DSI financial policies impacting investigator fees and payments.

• Lead communications and collaborate with study team members and site engagement roles at DS regarding site payment process, reporting and resolution of site payment issues.

• Monitor site payment processes to ensure timeliness, accuracy and compliance with contractual commitments, applicable laws and regulations.

• Support late payment and invoice issues from sites.

• Utilize site payment metrics for analysis, reporting, compliance and process improvement.

• Oversee the site payment reporting process.

• Serve as a point of contact to address site contract and budget related payment and tax-related matters in collaboration with relevant DS stakeholders (e. g. corporate tax team).

Performance Management, Quality Oversight

• Provide effective CRO performance management and oversight by establishing and monitoring performance and quality metrics and processes across studies and strategic vendor partnerships.

• Develop and implementing site budget, payment and reporting KPIs, tracking and reporting.

• Ensure appropriate performance and quality targets are established (via metrics and KPIs) and oversight is maintained to understand target realization.

• Ensure that an effective escalation framework for investigator grant issues and documentation of questions exist.

• Participate and provide input at appropriate functional oversight bodies.

• Support and drive relationship management and optimization efforts with both internal and external stakeholders.

• Design, implement a quality oversight plan for site budget development and administration, site payment processes and financial reporting activities.

• Provide oversight to ensure (i) the establishment of key checks and balances and (ii) a state of inspection readiness throughout the life of the clinical program & study.

• Establish, maintain and provide training and guidance to both SCBM team members other external roles to ensure full compliance with processes and requirements for investigator grant management and site payments.

People Management & Resource Planning

• Development of a plan for resourcing of activities within remit/scope.

• Provide resource management through forecasting and work-flow management.

• Manage employee direct reports and associated employee development duties.

• Depending on business priorities, manage contractor-based staff in collaboration with DS HR and vendor providers as appropriate.

Education Qualifications : (from an accredited college or university)

• Bachelor's Degree required

• Master's Degree Or equivalent combination of education, training and experience that provides the individual the required skills and abilities for this position preferred.

Experience Qualifications:

• Minimum 8-9 years pharmaceutical / biotechnology industry experience. required

• Demonstrated success in working cross-functionally in a global matrix organization; minimum 5 years' experience in managing or supporting global cross-functional processes. required

• Must have previous experience with Site Contract and Budget Management and held a leadership position in driving processes and oversight. required

• Must have previous experience with Site Contracts and budget management. required

• Must have experience in Clinical Operations and have a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines. required

• Excellent negotiation skills, conflict resolution, decision making skills, communication (oral and written) and presentation skills. required

• Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe. required

• Proven networking skills and ability to share knowledge and experience amongst colleagues. required

• Prior personnel management experience. required

Travel:

• Ability to travel up to 20% May require some travel (Domestic or global)

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.