Director, Alliance Management Job at Daiichi Sankyo, Inc.
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.
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 Director of Alliance Management will lead the strategy and manage the Alliance Management team to enable long term success in delivery of clinical trials and programs. The scope includes a global CRO coalition, a variety of outsourcing models via CROs, SMOs, and AROs, and a potential local and global FSP. The director has overall responsibility for developing and managing relationships with GCO contracted CROs and specialty vendors while maximizing the effectiveness, value, and efficiency. The Alliance Management Director will liaise with cross-functional leaders and their teams and evolve the model for the collaboration. He/she will ensure appropriate governance is in place to assure the highest quality delivery of clinical programs. The scope of the role includes study concept through end-to-end operationalization to maximize the value and efficiency.
Responsibilities
CRO Alliance and Vendor Management
- Implement strategy and direction to develop, manage, and innovate the model and relationships with CROs and specialty vendors. This includes a framework and operating model for different types of external relationships while maximizing the effectiveness, value, and efficiency.
- Partner with clinical study teams, Outsourcing & R&D Procurement to identify, select and qualify clinical operations CROs and specialty vendors (e.g., imaging, biomarker, central lab, adjudication). This may include new decision trees and forums based on the evolving DS portfolio and sourcing strategies.
- Contribute to sourcing scenario planning such as fully outsourced CRO and FSP. Lead cost analysis, benefit/risk assessments, and help to establish and implement an FSP model if this is the chosen path.
- Work with clinical study teams and functions to optimize planning, communication and collaboration between DS and external vendors including ensuring clear roles & responsibilities, points of contact, and process interfaces.
- Ensure appropriate oversight, governance and documentation requirements and processes to ensure the highest quality delivery of clinical programs. Scope includes oversight of how 3rd party vendors used by our CROs/vendors are being managed. Work with GCO leadership to identify the candidates to represent GCO on governance committees and outline scope of roles.
- Ensure CROs have a clinical trial diversity (CTD) plan in place, optimization of decentralized clinical trial (DCT) elements where applicable, and patient engagement strategies to optimize recruitment.
- Develop, monitor, and communicate CRO and specialty vendor performance, quality
- metrics (KPIs/KQIs) and status reports in alignment with DS performance metrics. Where applicable, develop and implement corrective action plans as needed to address any gaps or deficiencies.
- Partner with Outsourcing & R&D Procurement, Legal and other functions to follow the defined process and R&Rs for developing and managing clinical vendor contracts and budgets; identify areas for improvement in cycle time, efficiency, consistency etc.
- Collaborate with Academic Resource Organizations (ARO) and DS leadership to ensure consistent quality expectations for both ARO and CRO delivery utilizing CRO metrics.
- Partner in evolving the DS delivery sourcing strategy for the future portfolio, including different options for potential CRO/vendor engagement models.
- Engage with the strategic alliance vendor on the various day-to-day issues and opportunities arising from the collaboration. Ensure appropriate functions are engaged as appropriate.
- Partner with cross-functional study teams to prepare for and engage in interactions with strategic vendors to ensure successful outcomes for clinical programs (e.g. direction/input for joint operating and steering committee meetings, development and review of metrics, project-based analyses & recommendations).
- Lead the development of tools and training for the collaboration including vendor performance assessment in collaboration with R&D Excellence to inform outsourcing strategy and decision-making
Communications/Relationship Building
- Lead internally and externally to optimize cross-functional communication and issue resolution. Guide team in outlining the cause with action plans to any identified issues.
- Ensure governance structures are operating to full optimization (i.e. joint operating committees, executive steering committees, etc).
- Conduct regular reviews/meetings with senior management and functions across regions as appropriate to communicate current vendor status, key issues, milestones, etc. and to gather feedback.
- Develop dashboards/scorecards and communication/escalation pathways for appropriate functions. Engage with the strategic alliance vendor per escalation process, on appropriate issues and opportunities arising from the collaboration. Address areas of concern and provide recommendations to mitigate against poor performance.
- Responsible for development/maintenance of engagement plans (e.g., manuals, governance plans, etc.).
- Build and maintain collaborative relationships with key personnel both internally and with strategic alliance vendors.
- Influence various business units (globally as well as outside of R&D) to ensure consistency and support for the CRO/vendor strategic collaboration.
- Regularly communicate with CRO/vendor strategic alliance management counterpart and other key vendor stakeholders as needed, including ad hoc communications that require cross-functional involvement.
Metrics/Process Improvements
- Act as the lead for process optimization between the CRO/Vendor Strategic Partners and Daiichi Sankyo
- Identify gaps and champion development of Standards and templates, in partnership with R&D Excellence and other process owners/functional heads
- Ensure the monitoring approaches are relevant and efficient, including central monitoring, risk based, CRA ratio of experience, and have knowledge of current monitoring excellence trends.
- In collaboration with the appropriate functional roles develop, monitor, and communicate CRO and specialty vendor performance and quality metrics (KPIs/KQIs) and status reports (study level and across studies) at appropriate forums. Where applicable; develop and implement corrective action plans as needed to address any gaps or deficiencies.
- Create strategic level KPIs/KQIs and conduct ongoing analysis of outsourcing provider performance to ensure compliance of contracted services.
- Develop a plan for alliance audits and “health checks”.
- Liaise with all internal Daiichi Sankyo functions to ensure that key contract terms, including roles & responsibilities, milestones, financial transactions, progress reports, etc. are executed appropriately.
- Conduct ongoing lessons learned analyses and identify areas of focus to proactively identify and mitigate operational risk. Ensure analysis and sharing of lessons learned and identify areas for improvement with respect to clinical trial and CRO alliance management processes.
- Identify issues as they arise internally, and work with team leadership and other necessary stakeholders to formulate a position/strategy and participate/drive resolution.
General Leadership & Management
- Recruit, train, coach and develop staff to ensure development and deployment of key capabilities and to optimize their potential.
- Stay abreast of industry trends and knowledge base regarding CROs and specialty services/solutions and recommend innovative processes and tools to enhance trial designs and execution. Monitor evolving industry/regulatory environment and regulations for potential changes to clinical trial processes.
- Work with CROs and vendors to evaluate and implement clinical trial innovations and improvements (e.g. decentralized clinical trial elements, patient engagement strategies including diversity and inclusion, new technologies, etc.)
- Actively contribute to the development and implementation of key GCO strategies and plans as a member of the GCO Extended Leadership Team.
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 in the Sciences and a minimum of 10 years’ experience (8 years’ experience with Master’s degree; 5 years’ experience with PhD/PharmD) in pharmaceutical or biotechnology drug development required.
Experience Qualifications
-
Strong drug development experience with understanding of other functions relevant to the position.
- Experience in building a CRO strategic collaboration or managing a large complex CRO strategic relationships.
- Experience in building and managing FSP models.
- Strong drug development experience with understanding of other functions relevant to the position.
- Experience in building a CRO strategic collaboration or managing a large complex CRO strategic relationships.
- Experience in building and managing FSP models.
- Background in monitoring excellence
- Strong change management experience
- Project management, CRO alliance management or business development experience
- Ability to apply key CRO alliance management principles including how to understand/apply contract language, escalate/mitigate issues, and demonstrate creative problem-solving
- Ability to apply conflict management tools including de-escalation, mediation, and bargaining
- Strong MS Project and PowerPoint knowledge; excel and access as well as CTMS and SharePoint experience a plus
- Excellent verbal and written communication skills; strong analytical mind with the ability to think strategically in a complex operating environment; ability to problem solve quickly while working independently; strong negotiating and facilitation skills
- Demonstrate ability to identify, prioritize and resolve key project issues, while working with and coordinating demands from multiple customers both internally and at alliance vendors.
- Demonstrate ability to combine attention to detail with big picture perspective, operationalizing via excellence in project management and effectively managing multiple projects/priorities.
Licenses and Certifications
- Six Sigma certification preferred
Travel
Ability to travel up to 10%. Remote position that may require travel to home office and/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.
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