Daiichi Sankyo

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 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 Financial Transparency processes. The current process is supported by CRO partners and the SCBM group is required to build an effective collaboration with our strategic alliance partnership and a process for appropriate oversight of any outsourced or contracted activities utilizing both performance and quality measurements. The Associate Director, SCBM Financial Operations position provides leadership in strategy and process development to ensure the implementation of best practices in the timely and efficient delivery of site budgets. As a Subject Matter Expert (SME) for the site budget, payment 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. Included in the remit of the 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, financial transparency reporting (Sunshine and EFPIA) and timely payments to clinical sites.

The Associate Director, Financial Operations, SCBM'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:

SME Site Contracts & Budgets Financial Operations:

• Provide subject matter expertise, guidance and strategic planning in connection with the development and approval of global investigator site budgets.
• Liaise with the various functions in GCO and provide functional input to develop better defined process flows, roles and responsibilities to ensure smooth transitions and handoffs are maintained with rigorous oversight.
• Liaise with Legal, Compliance and Finance on company positions on legal developments, financial policies and regulatory guidance pertaining to site financial support, 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, Corporate Compliance, Finance, Clinical Development, Global Project Management, and Functional Quality groups, to ensure budget processes and expectations are mutually well understood.
• Overseeing the global site payment process for specific studies
• Provide guidance and support to the study teams when needed to ensure timely and compliant resolution of site budget issues.
• Managing issues, risks and challenges in the fair market value evaluation of site budget escalations
• Overseeing responses to budget escalations, analyzing trends and formulating innovative solutions
• Oversee the financial reconciliation process for Site Budgets
• Respond to CRO queries on DSI financial policies impacting investigator fees.
• Collaborate with the Regional Site Engagement Management (RSEM) team on the resolution of site financial issues.
• Serving as a point of contact to address site contract related payment and tax-related matters in collaboration with relevant DS stakeholders (e.g. corporate tax team)

Performance Management, Oversight:

• Provide effective CRO performance management and oversight by establishing and monitoring performance and quality metrics and processes across studies and strategic vendor partnerships.
• Ensure that an effective escalation framework for site budgets & CRO operational performance issues exists.
• Develop and oversee processes to ensure adherence to fair market value principles.
• Overseeing the development and reporting of site budget development, negotiation and finalization metrics
• Participate and provide input at appropriate functional oversight bodies.
• Support and drive relationship management and optimization efforts
• Provide support on GCO and non-GCO process improvement initiatives.
• Define/Update/Refine operating models to meet evolving business needs.
• Provide resource management through forecasting and work-flow management.
• Monitoring CRO site payment processes to ensure timeliness, accuracy and compliance with contractual commitments, applicable laws and regulations.
• Utilizing site payment metrics for analysis, reporting, compliance and process improvement

Financial Transparency Compliance:

• Accountability for the coordination of process with external GCO FT vendors
• Overseeing the GCO FT team’s review and reporting responsibilities
• Coordinating process improvements to improve data collection and analysis
• Collaborating with external stakeholders to ensure sound process and policy in FT reporting
• Responding to internal questions regarding GCO FT compliance
• Support annual GCO FT reporting.

Process Documentation and Process Improvement:

• Participate in technology initiatives to support efficiencies.
• Support build of Standard Operating Procedures and Instructions and ensure they are current and documented per quality documentation requirements and DS process management standards.
• Ensure appropriate performance and quality targets are established (via metrics and KPIs) and oversight is maintained to understand target realization
• Lead identification and implementation of improvements to the site budget, payment and reporting processes
• Monitoring controlled process documents for compliance with DS policies and changes in laws and regulations
• Work cross-functionally with stakeholders to identify when a process revision is required.

Quality Program Support:

• Provide expert guidance on the standards and areas of internal and external compliance.
• Design, implement a quality oversight plan for site budget development and administration, site payment processes and financial transparency activities.
• Provide oversight to ensure (i) the establishment of key checks and balances and (ii) a monitoring plan to ensure a state of inspection readiness throughout the life of the clinical program & study.
• Establish, maintain and provide training and guidance to other supportive roles to ensure full compliance with processes and requirements.

People Management & Resource Planning:

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

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

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.