Director, GMA Oncology, Clinical Operations

Location
Basking Ridge, NJ, United States
Posted
Jun 05, 2021
Ref
10915BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
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 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.

Summary
Lead execution and project management of Global Oncology Medical Affairs (GOMA) clinical activities. in adherence to all applicable regulations, guidelines and Daiichi Sankyo policies and procedures. Implement and drive a robust gov process and structure to ensure successful oversight of all activities at the Global, Regional and Local level. The Director will take responsibility for the clinical operational strategy and overall delivery (i.e. Operational Project Lead role) of clinical studies (incl. vendor management and oversight) and will represent GOMA Clinical Operations on the program and study teams. Support Global Medical Affairs Teams (GMAT) and GMAT leads on all program specific evidence generation activities. Oversight and management of budget items.

Responsibilities
  • Work closely with Outsourcing and Legal on RFP, Scope of Work documents, contracts, and any other documents necessary to ensure vendors are properly selected and contracted with, in accordance with DS policies and procedures. Oversee contracts once approved with regards to adherence to timelines, budgets, and scope of work.
  • Lead the internal and external functional study and/or project team(s) to develop a cross-functional, integrated study implementation plan including creation of initial study budget, study kick-off and team meetings. Ensure the timing of all study milestones and the associated budget meet the study plan agreed by the Project/Program Team(s).
    • Oversight of protocol /protocol amendment development, review and approval process, incl. integration of proper operational delivery aspects and logistics
    • Development or input into all other study related documents including but not limited to ICF, CRF guidelines, project management plans, monitoring plans, QA plans, clinical oversight plans, etc.
    • Lead site selection and site qualification discussions with functional study team and CRO as required.
    • Provide input into all other relevant study documents related to safety, regulatory, data management, clinical supplies etc. and oversees and manages the related functional study processes
  • Oversee the CRO and other vendors, provides timely strategic and operational input to ensure that the study is executed according to the agreed project plan. Actively conduct study risk assessment and study oversight.
  • Maintain quality and oversight of all study deliverables from start up to delivery of CSR and study archiving through close collaboration across functions, stakeholders, and vendors.
  • Represent Clinical Operations in Global Medical Affairs program team(s) and with alliance partner(s) and serve as interface for all related Clinical Operation tasks and activities
  • Ensure that relevant synopsis and protocols are reviewed by the applicable GOMA review committees. Ensure that global study documentation and tracking systems as well as budget planning and reporting systems are fully implemented and used by all stakeholders accordingly.
  • Responsible for management of CRO/Vendor performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions.
  • Create the budget at study start-up and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately.
  • Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Lead the creation of the Quality Oversight Plan (QOP) and ensure study team adherence to the QOP.Reg Interactions
  • Cooperate with all Regional MA and/or Clinical Operations Teams as well as other relevant regional and local functions to ensure concepts and protocols are reviewed at the Global level with documented minutes and actions
  • Ensure regional synopsis and protocols are reviewed by the applicable GOMA review committees. Ensure that global study documentation and tracking systems as well as budget planning and reporting systems are fully implemented and used by regions.
  • Establish and maintain strong partnership with Regional Clinical Operational and/or MA functions as well as other relevant regional and local functions.
  • Requires the supervision and management of functional study and/or project teams by providing instruction and direction of daily activities in support of project and GOMA Clinical Operations goals.
  • Drive and/or participate in the development of governance measures activities, e.g., Policies and SOP's as well as governance systems related to GOMA clinical operations activities, in collaboration with the Operational Excellence team.
  • 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.
  • Drive and/or participate in the development and implementation of GOMA Clinical Operations related management, tracking and documentations systems for interventional and non-interventional studies, CESR, IIS and EAP.
  • Provide oversight and input into all relevant budget management activities, such as planning, updates, and monitoring
  • Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation

Education/Experience
  • Bachelor's degree required. Master's degree in the Life Sciences is preferred. PhD, PharmD is of advantage
  • ≥ 8 years clinical ops experience in a Pharmaceutical company, and/or Contract Research Organization (CRO) Experience in global clinical study settings and in Medical Affairs preferred
  • Sound experience in interventional and non-interventional studies and IIS and Collaborative Externally Sponsored Research in a Medical Affairs environment highly desired and preferred
  • Experience in oncology desired
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.
Job Title
Director, GMA Oncology, Clinical Operations

City
Basking Ridge

Functional Area
Global Oncology Medical Affairs

State
New Jersey