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Job Requirements of Manager, CTBO Performance & Delivery:
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Employment Type:
Full-Time
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Location:
Basking Ridge, NJ (Onsite)
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Manager, CTBO Performance & Delivery
Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.
Job Summary:
The Manager, CTBO provides support to facilitate effective functioning in the following areas 1) GCO LT Forum(s) that focus on systemic aspects of performance and delivery of global clinical operations. 2) GCO capacity demand and supply & resourcing strategies 3) GCO metrics & dashboards 4) GCO technology needs 5) GCO financial processes The role is part of the Clinical Trial Business Operations (CTBO) group in Global Clinical Operations (GCO). Depending on business needs, the position may also assist CTBO and GCO on several business operations efforts and initiatives in addition to the stated areas above to meet GCO goals and vision. The position requires a strong mix of core clinical research operations knowledge and associated business processes and analytical acumen.
Responsibilities:
Oversee and facilitate GCO Leadership Forum(s)a) Support, in collaboration with the Head of PD, the successful planning, organization and delivery of intended goals of the PD meetings.) Lead, support and facilitate the Performance and Delivery (PD) Forum) Coordinate with relevant CTBO and GCO LT members effective planning and preparation of presentation materials including agendas for the PD Forum.) Identify key stakeholders (internal and external to GCO) and effectively collaborate and engage them to identify, communicate, prepare materials for PD forum discussions to resolve issues risks) Document and communicate key issues risks and outcomes of PD forum to internal and external to GCO stakeholders including other cross functional sr. leadership teams and forums) Support influencing the shift in mindset to foster transparency in communication of risks and issues, and collaboration for solutioning across GCO and cross functional leadership in support of meeting performance and delivery goals of global clinical operations
Support GCO Capacity Demand and Supply Resourcing Strategies) Support efforts to understand current and future capacity demand and supply needs of the GCO department spanning various delivery models (CRO or in sourced) via analyses.) Deliver standard and ad-hoc reports and analyses (in collaboration with PD organization) to help understand the book of work, resource capacity utilization, and GCO resourcing strategy.
Support adoption and refinement of GCO Metrics, Dashboards, and IT Needs) Scrutinize and help support the identification, consolidation, and oversight of GCO’s overall needs on metrics and technology and acting as GCO’s point of contact with MARS and DS IT related groups for annual IT portfolio prioritization and planning. Liaise with internal GCO functions including Functional Excellence team as needed.) Support identification, creation and business adoption of appropriate consistent metrics, targets, and key performance indicators (KPIs) that assess GCO’s overall health. Collaborate with all applicable GCO and non GCO functions including but not limited to GCO Functional Excellence, Strategic Vendor Oversight, Feasibility and DS Data Governance functions.) Liaise and partner closely with MARS and/or applicable DS IT team(s) as a GCO business partner on metrics/analytics technology needs for PD Forum.) In collaboration with other CTBO staff (as appropriate), generate ad-hoc analyses to support identification and implementation of innovative approaches to efficient delivery clinical study and programs.
Support GCO Financial Processes Liaise and collaborate with Finance and GCO functional heads to provide real-time tracking of departmental budget vs. spend, and highlight needs and gaps to support GCO resourcing strategies and goals, invoicing processes, and process level changes based on the evolving environment (e.g., country regulatory requirements).
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education:
Bachelor's Degree Bachelor's degree in Life Sciences and a minimum of 5 years' experience in pharmaceuticals or biotechnology drug development (master's degree with 3 years' experience) required
Experience:
4 or More Years Knowledge of ICH/GCP and regulatory guidelines/directives required
5 years of clinical research operations experience preferred preferred
Ability to work independently as well as collaboratively in a global, cross-functional and matrix environment required
Strong written and verbal communication skill required
Strong statistical modeling experience, and analytical and database related skills. required
Effectively negotiates and influences to solve high impact/scope challenges required
Strong leadership and facilitation skills required
Strong team management skills; Leads and influences the team; effectively manages functional or direct reports preferred
Good understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development preferred
Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint required
Travel:
Ability to travel up to 20% In house position that may require travel (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.