Associate Director, 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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 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 inspec