Associate Director, Clinical Operations

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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:

The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, 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 Associate Director is accountable for operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations. The role is primarily responsible for Operational Study Strategy and Study Execution and in addition may have the responsibility of managing 3 or more direct reports.

Responsibilities:

Study Management and Leadership:

• Has primary accountability for operational study-level timeline, cost, and quality deliverables.

• Lead the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent.

• Lead the creation of the cross functional Clinical Study Oversight Plan (CSOP) under the guidance of the study team leader and take a leadership role in ensuring study team adherence to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs and vendors.

• Provide operational input into study protocol profiles, final protocols and amendments

• Lead document review and coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.

• Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management.

• Lead the creation of the CRO scope of work in collaboration with Outsourcing Procurement Management.

• Lead trial feasibility and site identification activities in collaboration with the CRO and the study team. Oversee the site qualification process.

• Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure actions are taken (at the study team level and CRO and vendors levels) and/or issues / risks are escalated to project team level and relevant governance bodies.

• Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.

• Ensure adherence to internal procedures for study planning, study conduct, close out and reporting.

• Proactively assess potential risks to the study and propose mitigation plans.

• Monitor study budget against trial progress and bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.

• Ensure study budget is reconciled with Finance on an ongoing basis.

• Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).

• Ensures trial master file is complete and accurate for assigned stud(ies).

• If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for the assigned clinical study and responsible for leading the cross-functional study team, project managing and coordinating with internal stakeholders to ensure cross functional integration and delivery of study team plan and milestones (e.g. protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.). The study team leader will ensure meeting logistics, agenda and minutes are in accordance with DS standards.

CRO, 3rd Party Vendor Management and Oversight:

• Responsible for the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Specifically track operational study timelines and monitor operational performance metrics through the life of the study; Identify issues and propose solutions.

• Responsible for ensuring that the Clinical CRO(s) provide timely input and generate documents in a timely manner and with quality (e.g. communication plan, site monitoring plan, etc.) as per study plan.

• Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan. Oversee and track site initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO.

• Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is not limited to the CRO, but includes 3rd party vendors (e.g. translations, trial insurance, and central laboratory, etc.).

• Review CRO-generated reports such as monitoring visit reports, protocol deviation reports, and analysis of site metric reports. Identify areas of concern and either resolve, propose solutions, or bring to the attention of the operations lead of study team lead. Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection activities.

• Conduct and/or oversee the CRO oversight monitoring visits (CROOM visits) as outlined in the CSOP.

• Coordinate all operational activities under the guidance of the study team leader and liaise with CRO to support interim analysis, database lock and review of TLG before and after database lock.

• Oversee CRO study close-out activities (including but not limited to TMF reconciliation) and liaise with internal Functions within the study team to ensure drug destruction process and other study close out activities are completed.

Knowledge Management/People Management:

• This position may require the supervision of direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will:

• The supervisor should coach and guide their direct reports in support of their development needs, ensure individual development plans are in place, and facilitate conflict resolution on their behalf.

• Support Department in codifying existing knowledge and best practices; prepare training in area of expertise. Make recommendations for areas of improvement and innovation (study, or departmental level). Educate the team on adherence to SOPs, GCPs and on best application of operational tools and processes. May represent the organization as a prime contact for technical matters of significant complexity with possibility of leading a cross-functional initiative or workstream.

• Manage all employee-related activities throughout the year, including performance management and development.

• Identify and communicate the skills, behaviors and experiences required to develop employees.

• Set goals, reviews performance and provides feedback on a regular basis.

• Assist or Lead training SOPs, GCPs, operational systems, etc.

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

Education:

• Bachelor's Degree in a Life Sciences field and a minimum of 7 years of relevant experience. required

Experience:

• Experience in clinical operations methods and processes in industry setting. required

• Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. preferred

• Familiarity to a Japan-based organization is desirable.

Travel:

• Ability to travel up to 10% In-house office position that may require travel (global).

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.