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Associate Director/Director, IIS Lead GMA Oncology Full-time

at Daiichi Sankyo, Inc. in New Jersey (Published at 17-01-2020)

Join a Legacy of Innovation 110 Years and Counting!
With over 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. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group?s 2025 Vision to become a ?Global Pharma Innovator with a Competitive Advantage in Oncology,? Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
Job Summary:
Global lead for Investigator Initiated Studies (IIS) and externally sponsored collaborative research. Ensure adherence to all applicable regulations, guidelines and Daiichi Sankyo policies and procedures. Implement and maintain a robust governance process and structure to ensure successful oversight of all activities at the Global, Regional and Local level. Act of the author and responsible person for all IIS procedures, policies and guidance documents. Drive the IIS review committees. Act as business owner and SME for all IIS systems, including but not limited to system requirements, implementation and maintenance. Support Global Medical Affairs Teams (GMAT) and GMAT leads on all program specific IIS activities. Oversight and management of IIS budget items.
Responsibilities:
IIS Global Lead
  • Responsible for ensuring adherence to all applicable regulations, guidelines, policies and procedures
  • Implement and maintain a robust IIS and externally sponsored collaborative research governance structure and process
  • Support regions and countries on IIS study execution (including but not limited to issue resolution, contracting, budget, training, document management, milestone tracking)
  • Drive a robust study tracking process inclusive of milestones and documents
  • Responsible for the overall success of the management of the IIS review and approval committees for all applicable proposals
  • Ensure a collaborative working relationship between regions and global
  • Serve as the IIS SME on cross functional initiatives
  • Support GMATs as needed on IIS related activities
  • Maintain IIS website(s)
  • Develop and communicate study updates, IIS metrics and KPIs to applicable stakeholders
  • Ability to recognize trends and effectively implement process improvement and/or mitigation activities
  • Act as primary point of contact for all CAPA activities related to IIS

Vendor Management
  • Support and facilitate the creation of bid templates for the selection of vendors
  • Responsible for management of vendor performance to ensure adherence to scope of work within timelines and budget
  • Identify and evaluate potential partners which may be required to support IIS activities
  • Drive the selection of vendors and internal resources for proper oversight and management internally

Regional Support
  • Work with the Regional Teams and key stakeholders to drive alignment on key activities and expectations
  • Ensure regular updates provided to Sr Director on trial metrics and data
  • Establish strong partnership with Regional Operational managers to drive operational excellence in regions and countries for all IIS activities.

Process/Policies
  • Provide input to process standards and tools to achieve excellence in trial operations and management.
  • Support the development of clinical operations related Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable

IIS System
  • IIS end to end system
  • Oversee the selection of IIS system vendors, as applicable
  • Drive system requirements in alignment with all applicable regulations and business needs
  • Act as the business responsible to ensure that any IIS system is implemented, is operating and is performing in accordance with the business needs.
  • Act as IIS system business owner
  • FMA Webased Tool
  • Serve as business owner for tool
  • Ensure proper usage and training across global and regions

Budget
  • Responsible for global IIS budget, including but not limited to yearly planning, monthly spend, LE updates and variances. Ability to work cross regions to align and maintain budget.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Compensation and seniority level/title will be commensurate with experience and qualifications. Duties and responsibilities may vary based on the position level/title.
Education/Experience:
  • Bachelors degree or equivalent education/experience in life science/healthcare required
    • 3+ yrs w/M.S., 5+ years w/B.S. of relevant experience in pharmaceutical IIS preferred.
  • Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs.
  • Mindset of putting the patient first, as well as have a values-driven leadership style where integrity drive all behaviors, decisions, and actions
  • Working knowledge of clinical development process, regulatory requirements and GCP.
  • Must be highly organized and detail-oriented

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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