Director, GMA Oncology, Clinical Operations

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:
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), Collaborative External Sponsored Research, and Investigator Initiated Studies (IIS).

The Director will take responsibility for the clinical operational strategy and overall delivery (i.e. Operational Project Lead role) of clinical studies or EAP (incl. vendor management and oversight) and will represent GMA Clinical Operations on the program and study teams. This position may require future line management responsibility of Clinical Study Managers, who are primarily responsible for the tactical execution of the study.

The Director will be expected to take both strategic and tactical operational roles in order to deliver the study. At this level, the incumbent may also be expected to lead program(s) of studies. Furthermore, the Director is expected to also work in governance and clinical systems related developments and activities.

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 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 needs of the overall plan agreed by the Project/Program Team(s).

Across all programs, responsible for:
• 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 as well as ensure mitigation and contingency measures are prepared and implemented.

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.

Ensure all key stakeholders are aligned on the approach and the conduct of global studies/programs including but not limited to Regional Medical Affairs, Regional Clinical Operations, CSPV, Regulatory Affairs, Quality Assurance, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership.

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 GMA 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.

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. 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.

Clinical Operations Management/General
Participate in the development of governance measures, eg. Policies 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.

Participate in the development and implementation of GMA ClinOps related management, tracking and documentations systems for interventional and non-interventional studies, CESR, IIS and EAP.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

• Bachelor's degree required. A Master's degree in the Life Sciences is preferred. PhD, PharmD is of advantage
• ≥ 8 years clinical operations 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 as well as 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 Medical Affairs Oncology

State
New Jersey