Director, GMA Oncology Clinical Trial Management & Resources in Basking Ridge, NJ at DSI

Date Posted: 9/7/2021

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. 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.

Job Summary:

Externally Sponsored Research (IIS and Collaboration) Lead/Global lead for Investigator Initiated Studies (IIS) and/or Expanded Access Program (EAP) externally sponsored collaborative research. Ensure adherence to all applicable regulations, guidelines and Daiichi Sankyo policies and procedures. Implement and drive 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 and/or EAP review committees. Act as business owner and SME for all IIS systems and or , 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 and/or EAP budget items.
Responsibilities:

IIS and/or EAP Global Lead
  • Responsible for ensuring adherence to all applicable regulations, guidelines, policies and procedures
  • Implement and drive a robust IIS and externally sponsored collaborative research governance structure and process
  • Lead the support of regions and countries on IIS and /or EAP 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 and accountable for the overall success of the management of the IIS review and approval committees for all applicable proposals
  • Drive a collaborative working relationship between regions and global
  • Serve as the IIS and/or EAP SME on cross functional initiatives
  • Support GMATs as needed on IIS related activities
  • Maintain IIS and/or EAP website(s) if applicable
  • Develop and communicate study updates, IIS and/or EAP 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 and/or EAP
Vendor Management
  • Drive 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
  • Responsible for the development of process standards and tools to achieve excellence in trial operations and management.
  • Responsible and accountable for the development of clinical operations related Corrective and Preventative Action (CAPA) plans for issues of non-compliance as applicable
IIS System
  • IIS end to end system
  • Drive 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 Web based Tool
  • Serve as business owner for tool
  • Drive proper usage and training across global and regions
Budget
  • Responsible and accountable 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.
  • Clinical Operations Management Act of primary author or key contributor for procedures and SOP’s related to Global Medical Affairs clinical operations activities.
  • Collaborate with Quality Assurance, QC function and regulatory Operations to implement quality standards across all activities, systems and processes.
  • Support the implementation of CAPA in relation to sponsor’s audit or regulatory inspection.
  • Provide input into quarterly budget management activities
  • Drive and/or Participate in GMA driven initiatives
  • Study Review Committee Management Oversee company sponsored review committees for interventional and non-interventional studies (including those that are part of an alliance and/or other functions). This is inclusive of all medical affairs, HEOR and Epidemiology NIS studies.
  • Liaise with relevant internal and external (Alliance) stakeholders to continuously improve function of study review committees.
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 or equivalent education/experience in life science/healthcare required and
Master's Degree Life Sciences preferred

Experience Qualifications
  • 4 or More Years of relevant experience in pharmaceutical IIS and/or EAP w/M.S preferred
  • 10 or More Years of relevant experience in pharmaceutical IIS and/or EAP w/B.S preferred
  • Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs. preferred
  • Mindset of putting the patient first, as well as have a values-driven leadership style where integrity drive all behaviors, decisions, and actions preferred
  • Working knowledge of clinical development process, regulatory requirements and GCP. preferred
  • Highly organized and detail-oriented required
  • Experience in Medical Affairs and oncology preferred
  • Clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO). preferred
  • CRA and/or Study Site Coordinator experience preferred
  • PMP certificate preferred
Travel
Ability to travel up to 20% Standard office based physical demands, minimal 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.