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Senior Director, GMA Oncology Clinical Trial Management & Resources in Bernards, NJ at DSI

Date Posted: 3/5/2019

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary:
This position provides oversight and leads all aspects of Global Clinical Operations providing strategic and tactical guidance/ support for clinical staff with high degree of quality in the execution of all Global Medical Affairs medical activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines (i.e. Company Initiated Studies (CIS), Expanded Access Programs (EAP), Real World Evidence (RWE) programs, Investigator Initiated studies (IIS)). Ensure successful execution, timelines and clinical milestones. Accountable for overall Clinical Operation performance against key metrics. Accountable for all budget related management.

Responsibilities:
  • Clinical Operations Study/ Program Management
    • Company Initiated studies (CIS). Real World Evidence Studies, Expanded Access Programs
      • Ensure preparation, execution and reporting of all clinical trial activities, ensuring adherence to timelines, budgets, quality plans, and relevant ICH/GCP Guidelines
      • Provide strategic input into the development of the protocols to ensure designs are implementable to efficiently achieve the objectives.
      • Provide strategic input in the development of CRFs, ICFs, Monitoring Plans, final reports and publications as applicable.
      • Develop, implement and ensure adherence to timelines, program objectives and monitoring plans. Accountable for accuracy and timeliness of information in all databases and tracking systems.
      • Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, safety updates/ notifications, etc.
      • Ensure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)
    • Investigator Initiated Studies (IIS)
      • Provide oversight of the overall IIS process related to third-party Investigator Initiated Studies IIS as per the Standard Operating Procedure (SOP)(regional review, Global review, tracking of milestones as per contract)
      • Ensure the IIS process is revisited regularly to adhere to the (SOP) and identify and remediate/correct any gaps on a timely manner to ensure robust preparation and review by the Global IIS committee as well as proper documentation of decisions and document repository
      • Oversight of the IIS system for management of IIS review and approvals (IMPACT)
  • Oversight of Study Teams (ST) for GMA Medical Programs
    • Develop an overarching project management plan & anticipate and efficiently mitigate risks
    • Lead and manage the global multidisciplinary team to ensure all trial deliverables are met according to timelines, budget, quality standards, SOPs and Business Guidance; chair ST meetings, report study progress and issues with their resolution plan; lead trial level interactions with relevant functions including Drug Supply Management and local medical organizations
    • Lead team to develop functional center of excellence in clinical trial execution by identifying and implementing best-in-industry practices. Accountable for overall management of clinical trial team when applicable.
    • Ensure clinical operations teams regulatory and Good Clinical Practice (GCP) compliance. Comply with applicable regulations, GCP and corporate policies and procedures
  • Vendor/CRO/Supplier Management
    • Develop clinical outsourcing specifications incorporation with respective line functions to facilitate bid templates and selection of CROs; provide strong oversight of CROs.
    • Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level.
  • Managerial Responsibilities
    • Establish annual objectives for the Clinical Operation group. Participate in the hiring, on-boarding, training and mentoring of new staff.
  • Regional Support
    • Work with the Regional Teams to ensure concepts and protocols are reviewed at the GMAT level with documented minutes and actions. Ensure synopsis and protocols are reviewed at the PRG
    • Liaise with the Regional Operation manager to ensure alignment on the proper infrastructure to put in place as well as the expertise of the CRO
  • GMA LT responsibility
    • Coordinate with the GMA LT to ensure efficient and transparent allocation of Clinical operation resources, assignment of activities in support of program/trial deliverables and individual development needs.
  • Process/Policies
    • Develop and implement process standards and tools to achieve excellence in trial operations and management. In collaboration key stakeholders, drive implementation globally in a manner that creates consistency, efficiency and with a high level of compliance within GMA across compounds and projects.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Advanced degree or equivalent education/experience in life science/healthcare from an accredited college or university required.
  • 12 years of overall experience with Bachelor’s degree; 10 years of overall experience with Master’s degree; 7 years of overall experience with PhD or PharmD
  • ≥ 5-10 years of pharmaceutical clinical research experience
  • ≥ 5-10 years people management experience required, this may include management in a matrix environment. Global people management required
  • 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
  • Extensive knowledge of clinical development process, regulatory requirements and GCP.
  • Proven capabilities in clinical operations process improvements.
  • Considerable organizational awareness, including significant experience working cross-functionally and responsibility for internal resource estimation/allocation.
  • Medical/scientific knowledge of Oncology and/or Hematology desirable
  • Demonstrated vendor & project management experience
  • Ability to travel up to 15%

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.