Director, Performance & Delivery, Clinical Trial Business Operations

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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 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.   

Summary

The Director, CTBO position provides leadership and ensures effective functioning of the following areas: 1.) GCO LT Forum(s) that focus on systematic 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 Depending on business needs, the position may also lead and or assist the Head of CTBO on several business operations efforts and initiatives in addition to the stated areas above to meet GCO goals and vision. The position will also partner closely with the MARS (Metrics, Analytics, Reporting and Solutions) Team and other DS IT/data related teams as a business partner and representative of GCO and will require a strong mix of core clinical research operations knowledge and associated business processes and implementation experience of non-clinical projects.

Responsibilities

- Oversight of GCO Metrics, Dashboards and IT Needs

Responsible for consolidating and overseeing 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.

- Collaborate and support existing IT related projects and their project leaders to effectively navigate and mitigate high impact hurdles, advocate and liaise with applicable stakeholders (e.g. Legal, Privacy, Global Dev Information Management (GDIM), IT groups) to drive project to completion on time and within planned budget.

a) Lead and/or support identification, creation and business adoption of appropriate consistent metrics, targets, and key performance indicators (KPIs) that assess GCO’s overall health.

b) 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 and associated dashboards/reports.

c) In collaboration with MARS team drive and lead high level requirements for effective dashboards and reports for PDf) Lead and/or support identification and implementation of innovative approaches to efficient delivery clinical study and programs.

- Support GCO Financial Processes. Liaise with Finance dept as the GCO representative to understand GCO departmental budget, 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).

- People and Resource Management. This position may require the supervision of direct and indirect reports. In addition to providing training and direction for daily activities in support of goals, this job will conduct performance evaluations against goals for their direct reports. In addition, this job will coach and guide their functional and/or direct reports in support of their development needs, and provide real-time feedback on job performance. Develop plan for resourcing of activities within remit/scope. Ensure appropriate resources (employee and/or contractor-based) are available to support current and future clinical programs and studies.

- Lead, support and facilitate GCO Leadership Forum(s)

- In collaboration with CTBO Head support staff, and GCO LT establish refine the scope of areas to be included in the appropriate GCO Leadership Forum (called Performance and Delivery (PD) Forum) that is dedicated for identification and resolution of high impact and/or systemic issues risks impacting the performance and delivery of global clinical operations. Responsible for successfully planning, organization and delivery of intended goals of the PD meetings.

a) Lead, support and facilitate the Performance and Delivery (PD) Forum

b) Lead and coordinate with relevant CTBO and GCO LT members for effective planning and preparation of presentation materials including agendas for the PD Forum.

c) Identify key stakeholders (internal and external to GCO) and ensure effective stakeholder management. Collaborate with identified stakeholders to set expectations for PD forum discussions. Ensure appropriate key messages, asks, impact to goals is surfaced appropriately at the forum for review and discussion. Some key stakeholders include but not limited to GCO LT members, Functional Excellence, Feasibility, GCO Alliance Management, Clinical Trial Risk Managemente) Liaise and collaborate with Functional Excellence team to effectively raise status, impact, issues and risks, prioritization of current and future non clinical initiatives at PD Forum for planning and awareness.

- Lead and support communication of key outcomes of PD forum to internal and external to GCO stakeholders including GCO functional excellence efforts, and other cross functional sr. leadership teams and forums.

a) Lead 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

- Oversee and Guide GCO Capacity Demand and Supply Resourcing Strategies

a) Oversee and guide CTBO staff in appropriate planning, understanding and identification of gaps in overall GCO demand and supply of resources to meet GCO’s book of work. Scope includes building GCO specific processes to streamline resourcing related processes while aligning with any RD specific processes that may exist.

b) Oversee and guide efforts to understand current and future capacity demand and supply needs of the GCO department spanning various delivery models (CRO or in sourced).

c) Oversee, identify and deliver (in collaboration with appropriate IT and systems groups) adequate reporting and understanding of the active and future book of work, resource capacity utilization, current and upcoming gap to current and future portfolio. Effectively communicate these outputs and collaborate with GCO Leadership Team and other GCO Function Heads to identify and deliver solutions.

d) Ensure GCO resourcing algorithm needs and gaps are well understood and drive effective solutions with collaboration with internal and external stakeholders. (e.g. enterprise planning system/Trident)

e) Lead and support identification and execution of effective resourcing strategies for meeting GCO resourcing needs (clinical portfolio and non-clinical portfolio) in collaboration with GCO stakeholders.

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 Life Sciences field and a minimum of 10 years' experience in pharmaceutical or biotechnology drug development required
- Master's Degree In Life Sciences field and a minimum of 5 years' experience in pharmaceutical or biotechnology drug development preferred

Experience Qualifications

- 10 or More Years Knowledge of ICH/GCP and regulatory guidelines/directives required
- 7 or More Years A minimum of 8 years of clinical research operations experience preferred

Physical Requirements. In-house office position that may require some travel (global). 10% of Time.

Travel

Ability to travel up to 5% In-house office position that 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.