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.
Summary
The Senior Director of Clinical Operations will manage clinical operations staff to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Will represent DSPD Clinical Operations in a range of cross-functional groups, global functional committee(s) and initiatives intended to enhance function and company efficiency and productivity, regionally and globally. Will represent Clinical Operations on vendor governance bodies and ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and timing of operational deliverables are in place for all studies and programs. Will support the development of policies, procedures and training relevant to the Clinical Operations function.
Will ensure that global and local clinical studies are executed, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs) and relevant regulations Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
A key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This leader will also ensure a robust escalation and communication plan is in place for each CRO to best support each program.
This position will require line management responsibility of Directors, Associate Directors, Clinical Study Managers, who are primarily responsibility for the clinical operational and overall delivery and tactical execution of the clinical studies. The senior director will ensure a strong focus on competencies supportive of project management; vendor management and stakeholder management. At this level, the incumbent may be expected to serve as Program level Delivery Lead on large and/or complex programs, including those involving co-development (Alliance) partners.
Responsibilities:
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)
Experience Qualifications:
Travel:
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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