Senior Manager, Trial Delivery Leader, Oncology

Role Summary

The Senior Manager, Trial Delivery Leader (TDL) is accountable for clinical trial delivery, providing operational oversight of cross-functional deliverables for the Late Development or Early Development portfolio. The TDL leads a cross-functional trial team to build and deliver the trial operational plan, identifying and mitigating risks to effectively deliver assigned trials on time, on budget, and in a compliant manner.

Responsibilities

• Lead the Cross Functional Trial Team (CFTT) to develop the operational plan and end-to-end trial coordination.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones (support DBL/CSR/TLR planning and scope; define protocol deviations and resolution pathways).
• Proactively ensure that trial deliverables and milestones are met.
• Identify risks and ensure mitigation and contingencies are initiated and followed through.
• Ensure trial is operationalized in compliance with global health authority regulations and internal operating procedures and processes.
• Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight.
• Participate in process improvement activities at a trial, compound, and cross-DU level, as needed.
• Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
• Lead and ensure inspection readiness for the program through risk identification and readiness review.
• Provide leadership during Health Authority inspections and identify risks and mitigation plans at the program level for key issues.
• Mentor and support onboarding of new team members, particularly those in Trial Management.
• Foster employee engagement, inclusion, and Credo Behaviors.

Qualifications

• BS degree or equivalent; preferred areas include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 8 years in Pharmaceutical, Healthcare or related industries.
• Experience in and knowledge of the pharmaceutical development process.
• Clinical research operational knowledge and experience across multiple phases of studies (Phase I–IV); ability to manage all aspects of execution of a clinical trial.
• 2–3 years’ experience leading multiple aspects of a global clinical trial.
• Excellent leadership skills and proven ability to foster team productivity and cohesiveness.
• Experience of leading without authority in multi-functional, matrixed, and global environments.
• Excellent decision-making, analytical and financial management skills.
• Operate and execute with limited supervision.
• Experience mentoring/coaching others.
• Strong project planning/management, communication, and presentation skills.
• Travel up to 15–20% of the time, defined by business needs.