Executive Director, Data Management in Basking Ridge, NJ at DSI

Date Posted: 8/29/2021

Job Snapshot

Job Description

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

Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the data management strategy across regions. This position is responsible for performance of the function and the development of group members. This position also monitors trends in functional performance via quality, time, and cost indicators, and develops plans and leads the execution for improvements. Additionally, this position develops and executes strategies within the scope of BDM management and in collaboration stakeholders that are optimized across business units, regions, and functional areas to ensure successful outcomes for projects/studies. This position has sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data Capture/related applications and industry standards, and advanced skills partnering with CROs and other third-party vendors. This position has excellent verbal/written skills, analytical, organizational, and people management skills and collaborates effectively with stakeholders at different levels and from different disciplines and cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced experience working on Phase I-IV studies within the pharmaceutical industry across multiple therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills in continuous improvement, project management, change management, and risk management

Responsibilities
  • Leadership, Direction, and Strategy:
    • In collaboration with Clinical Development and Clinical Operations as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data management strategy across regions and across studies/programs.
    • Represents Data Management in governance bodies internally and externally with CRO partners and stakeholders.
    • Liaises with other function heads to ensure effective cross-functional collaboration and proactive communication throughout the drug development process.
    • Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions work.
    • Proactively identifies and manages risks for the data management function and supports functional risk identification/management efforts globally.
    • Serves as the internal Data Management expert to provide strategic thinking for outsourcing strategy. As a member of the CRO governance committee, provides strategic leadership in Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.
    • Ensures inspection readiness of all data management activities conducted internally or outsourced
  • Management of the function:
    • Provides strong leadership and inspiration to the Data Management function. Hires, develops, and retains talents. Responsible for the performance management of the Data Management function, including performance of outsourced data management activities.
    • Forecasts and manages Data Management resources needs, budget and timelines
    • Ensures Data Management has the appropriate skills, processes, and tools to achieve the R&D objectives.
    • Monitors trends in departmental performance via quality, time, and cost indicators, and makes recommendations for improvements.
    • Resolves and/or escalates issues encountered at the department level.
    • Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly (e.g., operational leadership teams).
  • Functional Expertise:
    • Serves as a Data Management expert accountable for robust R&D data management processes (including but not limited to CRF/eCRF design, all steps from database development to database release, data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance
    • Ensures that Data Management Plans are consistent and regulatory compliant across studies and programs.
    • Promotes Risk Based approaches to data cleaning and review
    • Proactively collaborates cross-functionally during interactions with Regulatory Authorities and other key external stakeholders (e.g., advisory committees and integration teams).
    • Serves as the Data Management leader representing R&D during regulatory inspections and internal audits pertaining to R&D activities.
  • Operational Efficiency / Continuous Improvement:
    • Leads standardization efforts in Data Management and ensure global implementation.
    • Promotes automation, innovation, process improvement and technology enhancement in Data Management to increase Drug Development efficiency
    • Provides oversight and leads the efforts to implement and develop Data Management processes and tools based on emerging trends, technology, and best practices.
    • Leads implementation of improvements and makes recommendations for regional/global implementation.
    • Actively contributes to the review of best practices within the function.
    • Maintains peer relationships with thought leaders in Data Management and related areas.
    • Leverages Data Management and related expertise to promote best practices across the Drug Development lifecycle.
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 with 15+ years of relevant experience required Master's Degree with 13+ years of relevant experience preferred

Experience Qualifications
  • data management and/or related work experience in a medical device or pharmaceutical company, or similar environment (e.g., CRO) required
Travel
Ability to travel up to 20% domestic and international 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.