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Senior Director, Data Management

2 months ago

Basking Ridge, United States Daiichi Sankyo Full time

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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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

 

Sr. Director Data Management contributes to the vision, direction and strategy for Data Management globally and executes the strategy regionally. This position is responsible for regional performance of the function and the development of regional team members. This position also monitors trends in functional performance via quality, time, and cost indicators, and makes recommendations for improvements. Additionally, this position recommends and executes strategies in collaboration with Senior Management and global stakeholders that are optimized across business units, regions, and functional areas to ensure successful outcomes for projects/studies.

 

This position has 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 interpersonal skills and collaborates effectively with stakeholders at different levels and from different disciplines and cultures. This position mentors/coaches within Data Management and cross-functionally. 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 medical device and/or pharmaceutical industry across multiple therapeutic areas and actively participates in 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:

  • Contributes to the vision, direction and strategy for Data Management in support of the advancement of the global portfolio.
  • Responsible for regional execution of the global strategy and performance of the function and regional team members.
  • Leads a team and is responsible for performance management, coaching and development of team members.
  • Acts as a Data Management point of contact for Senior Management and high-level internal and external stakeholders on global projects and/or programs
  • Makes decisions and provides solutions that impact the function regionally and collaborates with relevant stakeholders to make recommendations/decisions that impact the function globally.
  • Collaborates cross-functionally to resolve issues on programs and collaborates globally to resolve global issues.
  • Liaises with other functions to ensure effective cross-functional communication throughout drug development process.
  • Establishes and manages effective collaborations with external drug development partners by contributing to development of common standards and process via functional committees
  • Proactively identifies and manages risks for the function regionally and supports functional risk identification/management efforts globally.

     

    Project Management:

  • Contributes to departmental resource planning, budgeting, and timeline setting.
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 or cross-functionally. Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly (e.g., operational leadership teams) and quality deliverables are achieved on time and budget.

 

Functional Expertise:

Serves as a Data Management expert regionally/globally. Acts as coach/mentor at the department level and regional Data Management expert. Collaborates cross-functionally during interactions with Regulatory Authorities and other key external stakeholders (e.g., advisory committees and integration teams).

 

Operational Efficiency / Continuous Improvement:

Ensures Data Management has the appropriate skills, processes, and tools to achieve regional/global objectives. Influences Data Management processes and tools based on emerging trends, technology and best practices. Leads functional or organizational initiatives to drive overall business strategy. (for example: Artificial Intelligence and Machine Learning (AI/ML) within Data Management and contributes to AI/ML implementation initiatives cross-functionally and/or globally). Actively contributes to the review of best practices within the function and makes recommendations towards achievement of operational excellence. Maintains peer relationships with thought leaders in Data Management and related areas. Coordinates with key stakeholders regionally/globally to optimize cross-functional interfaces and collaboration. 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

Bachelor's Degree in life sciences or related field required Master's Degree in life sciences or related field preferred

 

Work Experience

13 years (or 11 years with Master's Degree) data management and/or related work experience in a medical device or pharmaceutical company, or similar environment (e.g., CRO) required 7 or More Years managing people required 7 or More Years managing initiatives required

 

Competencies

End-to-end clinical trial experience directing/overseeing data management services and deliverables (e.g., CRFs, edit checks, lab data processing, medical coding, data review listings, database locks, reconciliation) for multiple studies Skilled in using Electronic Data Capture, DM review tools, and Microsoft Office applications (e.g., EXCEL, WORD, PowerPoint, etc.) Able to lead program and initiative teams to achieve high-quality, on-time deliverables Effective management and development of people Demonstrated communication, problem-solving, and collaboration skills with people at different levels and from different disciplines and cultures Demonstrated excellent project management skills Demonstrated negotiation and conflict resolution skills Demonstrated team building skills Excellent interpersonal skills Able to manage multiple priorities Strategic thinker and leader Demonstrated decision-making skills Demonstrated leadership skills Innovative Demonstrated ability to function as DM SME in internal audits and/or regulatory on-site inspections Knowledge of clinical trial operations, clinical trial data flow, pharmacovigilance, and biostatistics Knowledge of industry standards and best practices in clinical data management and relevant Good Clinical Practices (GCP) and regulatory requirements. Knowledge of clinical coding Knowledge of CDISC – specifically SDTM Experience working with studies using local lab data management processes Experience in continuous improvement, change management, and risk management Extensive knowledge of different systems and technologies used in clinical data management Experience in resource allocation and budgeting Experience in CRO/FSP oversight, budgeting, and contracts Experience in vendor management especially in relationship management Experience in data management of complex clinical trial designs and processes (e.g., endpoint adjudication) Experience in regulatory submissions, regulatory inspections, and/or internal audits


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.