Executive Director, Global Clinical Operations Study Management Group Head - Daiichi Sankyo Inc.
Basking Ridge, NJ
About the Job
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 16,000 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 Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic oversight of study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. The teams reporting into this role must ensure robust strategic and operational planning has been incorporated throughout the governance process, to oversee delivery of projects to plan and to drive standardization and operational excellence across a portfolio of work.
Responsibilities
- Partner with the VP in developing the functional discipline through (i) functional-area leadership, (ii) keeping abreast with latest functional development in the pharma industry, (iii) supporting consistency, coherence, and compliance, (iv) establishing area-relevant standards, (v) encouraging innovation.
Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key stakeholder peer functions to ensure strong collaboration and early operational input into study design and trial delivery planning and execution
Ensure scientific concepts and business priorities are considered to provide strategic global leadership for the clinical operations staff working on clinical programs in scope/portfolio.
Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO Study Optimization to assess and plan for Ph I – III study team delivery and transitions. This includes engagement with feasibility, CTD, RSEM, and site contracts and budget management.
Ensure delivery of all operational components of global programs within scope, either through external partners (CRO, ARO, etc) or internal delivery models
Act as a key point of escalation for issues impacting across program for both internal and external stakeholders. Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.
Support, where needed, internal program/study review meetings preceding governance investment decision meetings
Provide strategic leadership to drive projects and foster a performance driven global culture
Accountable for the creation of an environment that inspires, motivates, and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the healthcare system.
Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.
- Functional leadership of up to 10 employees who manage the delivery
Ensure capability build, individual development, and performance management
Accountable for resource management within respective portfolio and collaborating with peers to optimize talent in the organization.
Ensure the GPT GCO reps are functioning at a high and consistent level
Drives a feedback-oriented culture
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
Experience Qualifications
- BS/MSA in related discipline, or equivalent work experience required
- 15+ years industry or related experience required
- Extensive early/late stage drug development experience ideally including time in role such as a Global Project Leader at Sr. Director level or equivalent preferred
- Relevant therapeutic experience and proven ability to learn new indications required
- Proven global line management expertise; experience of performance management and development of Director+ level staff required
- Proven experience in leading and implementing improvement initiatives, novel technology or techniques in the context of clinical development required
- Proven change management experience required
- Proven strategic and innovative thinking required
- Functional management experience, managing resourcing and budget planning/oversight required
- Ability to collaborate and establish a well-connected network with other Early/Late Leaders and Clinical Operations Leadership required
- Demonstrated ability in influencing others in a matrix environment required
- Awareness of external competitive environment and operational practices required
- Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment required
- Excellent written and verbal communication skills required
- Willingness to travel both domestic and international required
- Proven ability to develop successful collaborations with internal and external partners required
- Maintains high standards, including a commitment to Daiichi Sankyo values, policies and employment principles required
Travel
Ability to travel up to 20%. Some domestic and international travel expected
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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
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 16,000 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 Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic oversight of study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. The teams reporting into this role must ensure robust strategic and operational planning has been incorporated throughout the governance process, to oversee delivery of projects to plan and to drive standardization and operational excellence across a portfolio of work.
Responsibilities
- Partner with the VP in developing the functional discipline through (i) functional-area leadership, (ii) keeping abreast with latest functional development in the pharma industry, (iii) supporting consistency, coherence, and compliance, (iv) establishing area-relevant standards, (v) encouraging innovation.
Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key stakeholder peer functions to ensure strong collaboration and early operational input into study design and trial delivery planning and execution
Ensure scientific concepts and business priorities are considered to provide strategic global leadership for the clinical operations staff working on clinical programs in scope/portfolio.
Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO Study Optimization to assess and plan for Ph I – III study team delivery and transitions. This includes engagement with feasibility, CTD, RSEM, and site contracts and budget management.
Ensure delivery of all operational components of global programs within scope, either through external partners (CRO, ARO, etc) or internal delivery models
Act as a key point of escalation for issues impacting across program for both internal and external stakeholders. Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.
Support, where needed, internal program/study review meetings preceding governance investment decision meetings
Provide strategic leadership to drive projects and foster a performance driven global culture
Accountable for the creation of an environment that inspires, motivates, and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the healthcare system.
Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.
- Functional leadership of up to 10 employees who manage the delivery
Ensure capability build, individual development, and performance management
Accountable for resource management within respective portfolio and collaborating with peers to optimize talent in the organization.
Ensure the GPT GCO reps are functioning at a high and consistent level
Drives a feedback-oriented culture
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
Experience Qualifications
- BS/MSA in related discipline, or equivalent work experience required
- 15+ years industry or related experience required
- Extensive early/late stage drug development experience ideally including time in role such as a Global Project Leader at Sr. Director level or equivalent preferred
- Relevant therapeutic experience and proven ability to learn new indications required
- Proven global line management expertise; experience of performance management and development of Director+ level staff required
- Proven experience in leading and implementing improvement initiatives, novel technology or techniques in the context of clinical development required
- Proven change management experience required
- Proven strategic and innovative thinking required
- Functional management experience, managing resourcing and budget planning/oversight required
- Ability to collaborate and establish a well-connected network with other Early/Late Leaders and Clinical Operations Leadership required
- Demonstrated ability in influencing others in a matrix environment required
- Awareness of external competitive environment and operational practices required
- Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment required
- Excellent written and verbal communication skills required
- Willingness to travel both domestic and international required
- Proven ability to develop successful collaborations with internal and external partners required
- Maintains high standards, including a commitment to Daiichi Sankyo values, policies and employment principles required
Travel
Ability to travel up to 20%. Some domestic and international travel expected
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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
Source : Daiichi Sankyo Inc.