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 Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, EU Directives, and International Conference on Harmonization (ICH) guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects. Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative research studies being highly desirable.
Responsibilities:
Lifecycle Management: Oversee and manage the complete lifecycle of externally sponsored research, including both IIS and collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.
Operational Strategy: Develop and implement ESR team operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing potential issues proactively and ensuring adherence to timelines.
Program Leadership: Lead and manage multiple research programs, demonstrating expertise in both strategy formulation and operational execution in the field of externally sponsored research. Provide clear direction and guidance to project teams.
Committee Facilitation: Facilitate review committee meetings, ensuring comprehensive documentation of meeting outcomes, decisions, and action items. Coordinate with stakeholders to ensure timely follow-up and resolution of issues.
Clinical Trial Management: Oversee clinical trial functions including CTA negotiations, Fair Market Value evaluations, milestone follow-ups, study enrollment updates, study reports, and closeout procedures. Work closely with study site operational staff to ensure timely and accurate updates.
Project Management: Demonstrate advanced project management skills, facilitating discussions with internal and external cross-functional teams. Present findings and project statuses to cross-functional leadership and alliance management teams.
Budget Management: Exhibit strong budget management experience, including forecasting, reforecasting, and managing plan vs. actuals. Preferably, have experience managing global studies involving multiple currencies and complex financial tracking.
Vendor and Site Management: Direct and enhance interactions with investigator sites and other external vendors to ensure projects are delivered on time, within budget, and meet high-quality standards. Ensure effective communication and issue resolution.
Communication and Collaboration: Foster and maintain effective communication channels within a global, multi-disciplinary team environment. Ensure alignment and collaboration across functions, regional ESR and Medical teams as well as alliance partners, promoting a cohesive team approach.
Regulatory and Safety Compliance: Understand study conduct from supply chain/drug forecasting to safety and regulatory requirements related to studies using investigational drugs and commercial products. Demonstrate experience in various types of studies across all phases, with a preference for oncology.
People Management:
This position may require the supervision of functional and/or direct reports by providing instruction and direction of daily activities in support of goals.
Assume potential line management responsibilities for ESR Managers focused on the tactical aspects of study execution. In their absence, take on both strategic and tactical responsibilities to ensure study continuity and success.
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
4 or More Years relevant working experience in externally sponsored research, including IIS and collaborative studies required
4 or More Years in a clinical management setting required
A robust background in navigating complex regulatory environments and achieving study objectives efficiently and effectively required
Strong understanding of Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines required
Excellent communication, organizational, and problem-solving skills required
Proven people management experience, demonstrating effective leadership and team development preferred
Ability to travel up to 10% In-house office 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.
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