Senior Manager, Trial Delivery Leader, Oncology

Role Summary

Senior Manager, Trial Delivery Leader, Oncology is accountable for clinical trial delivery across Late Development or Early Development portfolios. The role leads a cross-functional trial team to build and deliver the trial operational plan, identify and mitigate risks, and ensure trials are conducted on time, on budget, and in a compliant manner. Remote work options may be considered on a case-by-case basis. Locations include La Jolla, California; Raritan, New Jersey; Spring House, Pennsylvania; and Titusville, New Jersey.

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 (e.g., 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 being initiated and followed through.
• Ensure trial is operationalized in compliance with global health authority regulations and guidelines 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 & 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 reviews; provide leadership during Health Authority inspections and on the identification of 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 Life Sciences fields (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); must have the ability to manage all aspects of execution of a clinical trial.
• 2-3 years’ experience leading multiple aspects of a global clinical trial.
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
• Experience of leading without authority and in multi-functional matrixed and global environments.
• Excellent decision-making, analytical and strong financial management skills are essential to this position.
• Operate and execute with limited supervision.
• Experience mentoring/coaching others.
• Strong project planning/management, communication and presentation skills.

Education

• BS degree or equivalent; Life Sciences fields (Biology, Chemistry, Biochemistry, Nursing, Pharmacy) preferred.

Additional Requirements

• Travel up to 15-20% of the time, defined by business needs.