Associate Director, GMA Oncology Clin. Ops Expanded Access Program in Bernards, NJ at DSI

Date Posted: 11/5/2018

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:
The Associate Director, GMA Oncology Clinical Operations Expanded Access Program will 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 company sponsored studies (interventional and non-interventional), Expanded Access Programs (EAP) and Investigator Initiated Studies (IIS).

A key focus will be the oversight of, and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study team. The Associate 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 Associate Director will take responsibility for the clinical operational strategy and overall delivery of the clinical study or EAP (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.

Responsibilities:
  • 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 CRO 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 CRO). Take responsibility to ensure meeting logistics, agenda and minutes are in accordance with DS standards.
    • Oversee the CRO 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.
  • CRO/Vendor and Quality Oversight
    • Responsible for management of CRO(s)/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.
    • 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. Be aware of and be able to predict deviations or potential noncompliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to senior management or the appropriate Governance Committee.
  • People Management
    • This position may require the supervision of functional and/or direct reports by providing instruction and direction of daily activities in support of goals.
  • 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.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Qualified candidates must have a Bachelor’s degree from an accredited college or university, preferably in life sciences; Master’s degree (Life Sciences) is preferred.
  • 7 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.
  • Demonstrates advanced knowledge of design and phases of clinical studies on a global scale, global regulatory issues, CRO operations, and compliance practices
  • Understands, identifies, mitigates, and communicates risks at the study or program level.
  • Effectively leads and influences within the matrix at the study level; manages functional or direct reports.
  • Sound understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development.

Ability to travel up to 10% either global or domestic 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.