Executive Director, 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 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. 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 Executive Director, Clinical Trial Business Operations will set strategy and direction for the Clinical Trial Business Operations organization within Global Clinical Operations & Planning (GCOP) and as a key member of the GCOP Leadership Team will also contribute to shaping and implementing operational and talent strategies across GCOP. This position will provide leadership and oversight of several key functions including Regional Site Engagement Management (RSEM), Trial Feasibility & Site Identification, Clinical Records & Systems, Study/Resource Planning, and Biosample Operations. This includes creating or enhancing Site Engagement, Feasibility, and Study Planning capabilities in line with DELTA and Development Operations strategies.

Responsibilities:

Set strategy and direction for the Clinical Trial Business Operations organization within Global Clinical Operations & Planning (GCOP) encompassing Regional Site Engagement Management (RSEM), Feasibility & Site Identification, Clinical Records & Systems, Study/Resource Planning, and Biosample Operations.

Oversee the creation and deployment of the new global RSEM organization, ensuring that effective regional and site-specific engagement strategies are developed and implemented and that relationships with key sites are optimized with a positive impact on site performance & metrics. Ensure this capability is leveraged to provide key information for site selection and to enhance the ability of sites to better support the conduct of Daiichi-Sankyo studies.

Guide the creation and deployment of the new Feasibility & Site Identification organization and champion the development and utilization of effective analytical tools that inform trial feasibility assessments, site selection decisions, timeline planning, and risk mitigation strategies.

Provide the necessary leadership and support to enable creation and effective implementation of a specialized Study/Resource Planning function designed to enhance planning and execution of studies across clinical study teams. Ensure this role is successfully integrated into the organization, including strong partnerships with Global Clinical Operations (Study Management) and Global Project Management.

Ensure that the Clinical Records & Systems organization delivers on its expanded mission to identify, maintain, and optimize clinical systems and solutions supporting Clinical Development Operations and broader DSPD functions, globally. This includes key systems such as eTMF Vault, CTMS, and other yet to be defined clinical systems and legacy systems and processes. Stay abreast of emerging technology trends and influence key stakeholders in the organization as needed to shape and adopt new clinical trial technologies.

As a member of the GCOP Leadership Team, actively contribute to shaping and implementing key GCOP strategies and plans including talent and organizational strategies, processes, and technologies.

Define and implement talent strategies across Clinical Trial Business Operations that result in identification and development of key talent/capabilities and drive a high level of performance, accountability, and employee engagement across the organization

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

Education/Experience:

Bachelor's Degree with minimum of 15 years' experience in pharmaceutical or biotechnology drug development.

• Broad knowledge and experience in global clinical trial planning and execution
• Senior management experience in clinical operations/clinical trial management & enabling technology solutions or related field, leading a medium to large organization and influencing senior-level management and key stakeholders. Includes strong track record of leadership of multiple clinical operations functions with 5+ years of line management experience including management of senior staff with accountability to therapeutic area development teams (highly matrixed organization) and management of staff across multiple sites/regions.
• Demonstrated ability to design and lead organizational and process /systems changes in a highly matrixed global environment
• Ability to provide leadership and to foster a collaborative, highly integrated culture, providing leadership and ability to enable transformative change to the Clinical Trial Business Operations team as required to deliver goals
• Ability to define core competencies, create infrastructure and set up strategic roadmap for delivery of Clinical Trial Business Operations goals
  Experience managing operational and resource budgets
• Experience with management of outsourced work and CRO governance
• Effective and influential communication, self-management, problem solving and organizational skills
• Demonstrated ability to build and maintain strong internal and external partnerships and coalitions, and to effectively collaborate across the organization
• Experience with delivering presentations before executive staff
• Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating through ambiguity
• Expert knowledge of ICH/GCPs and existing and emerging global, regional, and local country regulatory and compliance requirements for clinical research (Americas, Europe, Asia and Japan); experience with global regulations and global regulatory inspections is required. Familiarity with industry interpretations to ensure compliance while reducing complexity is desired
• 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.

Job Title
Executive Director, Clinical Trial Business Operations

City
Basking Ridge

Functional Area
Global Clinical Operations & Planning

State
New Jersey