Associate Director, Study Delivery Lead - Global Clinical Operations - Phase I Oncology

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.   

• 2+ years in FIH/Phase 1 Oncology Clinical Trials Preferred

• The SDL is an experienced matrix leader.

Job Summary:

The Study Delivery Lead (SDL) Associate Director - leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the accountability for 1 or several complex studies in various settings including Phase I-III, within a delivery model comprising of outsourced studies or outsourced studies with elements of insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Health Authority regulations, International Conference on Harmonization (ICH) guidelines and local regulations, as required.

The SDL is accountable for operational planning and execution at the study level with responsibility for clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget. The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate with the core and extended team to ensure robust CRO oversight including 3rd party vendors to achieve study milestones and deliverables according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics, Analytics, Reporting and Solutions (MARS) team to drive and monitor progress.

The SDL fosters an environment where the core study team maximizes their expertise and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other governance level as needed The SDL will have regular interactions with key internal and external stakeholders to discuss project status, escalate issues, and troubleshoot inquiries. For this role, strong written and verbal communication skills in English, operational leadership, and decision-making, ability to delegate, strategic thinking, conflict resolution, clinical project management experience and attention to detail are required. The SDL is an experienced matrix leader and serves as a mentor to more junior colleagues on clinical trial execution. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations.

The SDL is the reference and role model within the study delivery lead team that drives the culture for a healthy team. The role is primarily responsible for Operational Study Strategy and Study Execution while exhibiting leadership qualities.

Responsibilities:

• Lead the core study team while project managing and collaborating with internal stakeholders to ensure cross functional integration and delivery of study milestones (e.g. protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.)

• Ensure operational study-level timeline, budget, deliverables and quality management-Facilitate escalation and resolution of issues with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead).

• Where appropriate, may delegate certain responsibilities to Study Manager(s) assigned to the study

• Protocol Development, and Team Assembly-Contribute to and interface with different levels of study governance, as required-Oversee the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies)

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

• Participate in protocol and amendment review. Contribute to the development of and oversee delivery timelines of ICF, IB and safety communications, DSUR, IND.-Partner with other functional leaders to address core study team gaps and ensures accurate and complete study team list is maintained.

• In partnership with the lead physician, Clinical Scientist and all study team members, accountable for the co-ordination and conduct of feasibility process for protocol development in alignment with the CDP/IEP.

• Application of feasibility analysis to manage study implementation in the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery

• Lead the CRO and vendor selection process and scope of work in collaboration with the study team and Procurement Management.

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

• Assist Data Management with development of the clinical database (edit checks, CCG development, and UAT)

• Study Conduct and Oversight-Ensure operational adherence to the clinical study oversight plan

• Reinforce CRO/Vendor accountability for trial execution and quality data delivery. Foster a culture of empowerment and accountability for CRO to resolve study issues internally, raising such for DS action per exception/defined criteria for escalation-Monitor clinical trial performance and quality metrics and share with study team and GPT 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-Lead escalation and resolution of issues with CRO/ vendors/ site/ country performance including serious quality incidents and serious breaches of GCP. Triage, resolve or escalate study issues /risk mitigations as per JOC/ESC and other established forums. The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the absence of Asset Lead).

• Monitor study budget against trial progress and Inform Finance of deviations-Review and approve Vendor invoices, including investigator grants and pass through costs.

Quality and Inspection Readiness:

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

• Serve as primary SME engaged in dialogue with inspector(s) to address study inquiries throughout course of HA inspection-Ensure trial master file is complete and accurate for assigned stud(ies).

• Ensure that a study level operational risk management plan is in-place and applies a smart-risk taking philosophy

• Responsible for the delivery, oversight, performance and management of 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.

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

Education:

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

Experience:

• Experience in global clinical operations methods and processes in industry setting is required

• Experience considered relevant includes clinical or basic research in a pharmaceutical company, a medical device/Diagnostic company, Academic Research Organization (ARO), hospital/medical setting or Contract Research Organization (CRO). Clinical Project Management experience required. required

• CRA experience is preferred

• Familiarity with a Japan-based organization is beneficial preferred

• Strong Global Oncology therapeutic area experience required.

• The SDL is an experienced matrix leader.

Travel:

• Ability to travel up to 10%

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.