Manager/Assoc. Director, Clinical Trial Mgt & Resources, GMA Oncology

Basking Ridge, NJ, United States
Nov 20, 2020
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Join a Legacy of Innovation 110 Years & 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:
  • Lead execution and project management of Global Medical Affairs clinical 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. The types of clinical activities supported include Collaborative external sponsored studies (CESR)and Investigator Initiated Studies (IIS).
  • A key focus will be the oversight of, and interactions with research sites, regional Medical team and other external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study team.
  • The Assoc. Director will be expected to work in a collaborative, global environment and establish good communication with colleagues in other functions and across regional locations.
  • The Assoc. Director will take responsibility for the clinical operational strategy and overall delivery of the Collaborative study or IIS (i.e. Delivery Lead role) and will represent Clinical Operations on the study team. This position may require future line management responsibility of Clinical Study Managers, who are primarily responsible for the tactical execution of the study. In the absence of Clinical Study Managers, the Associate Director will be expected to take both strategic and tactical roles in order to deliver the study. At this level, the incumbent may be expected to lead a program of studies.

Study Planning, Budget and Execution
  • 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 study team to develop a cross-functional, integrated study implementation plan including creation of initial study budget. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall plan agreed by the Project Team.
  • Lead site selection and site qualification discussions with study team and vendors as required.
Across all programs, responsible for:
  • oversight of protocol /protocol amendment development, review and approval process
  • incorporating the proper operational delivery aspects and logistics into the protocol
  • development or input into other study related documents including but not limited to ICF, CRF guidelines, project management plans, monitoring plans etc
  • input into other relevant documents related to safety, regulatory, data management, clinical supplies etc.
Lead the study team kick-off meetings and subsequent team meetings (DS alone or with vendors). Take responsibility to ensure meeting logistics, agenda and minutes are in accordance with DS standards.

Oversee the CESR program and other vendors timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans.

Maintain quality and oversight of all study deliverables from start up to delivery of CSR through close collaboration across functions, stakeholders and vendors. As required, the Associate Director provides operational input into regional Medical Affairs studies.

Study and vendor and Quality Oversight
  • Responsible for management of the study site relations and any 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. Whenever possible, resolve issues that have been escalated or if warranted, take issues to senior management or the appropriate governance committee.
  • 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 CESR 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. Be aware of and be able to predict deviations, or potential non-compliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to senior management or the appropriate Governance Committee.
Clinical Operations Management/General
  • Participate in the development of procedures and SOP's related to Global Medical Affairs clinical operations activities, in collaboration with 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.
  • Provide input into quarterly budget management activities.
  • Participate in GMA driven initiatives
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

  • A Bachelor's degree in the Life Sciences is required. Master's degree (Life Sciences) is preferred.
  • Assoc. Director level: 7 years clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO).
  • Manager level: 4 years clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO).
  • Experience in Medical Affairs and oncology desired; EAP experience highly desired and preferred. CRA and/or Study Site Coordinator experience is also considered relevant. PMP certificate a plus.
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
Manager/Assoc. Director, Clinical Trial Mgt & Resources, GMA Oncology

Basking Ridge

Functional Area
Global Medical Affairs Oncology

New Jersey