Director Program Operations Leader, Oncology

Director Program Operations Leader (POL) – Oncology

Responsibilities:
- Lead and set/implement operational strategy for delivery of complex clinical programs in Clinical Trial Management (CTM)
- Manage clinical operations activities and decisions for assigned program(s), including quality, timelines, and budgets, in line with regulations, ICH/GCP, and SOPs
- Ensure overall success of clinical study team(s); maintain program status/issue visibility and proactively communicate risks/changes impacting quality, timelines, and/or budget
- Provide operational insight for feasibility, timeline, and cost estimates; contribute input to Clinical Study Concepts (CSC)
- Oversee clinical study timelines and support study delivery through protocol design, feasibility, start-up, and conduct phases
- Develop/implement operational strategy from Clinical Study Concept through Final Protocol; drive best practices and consistency across program study teams
- Own/oversee clinical study budgets through lifecycle; ensure initial budget review/approval and communicate changes to TA Operations Leader as appropriate
- Drive decision-making integrating operational considerations to ensure goals are attainable prior to implementation
- Act as point of contact for program/study-level escalation; review metrics/KPIs to track progress
- Create and implement risk mitigation strategies; provide innovative operational solutions
- Drive vendor selection/management strategy; manage CRO/vendor(s) for program-level deliverables and partner relationships

Qualifications:
- Bachelor’s degree
- Minimum 12 years of related in-house sponsor-side pharmaceutical experience, including 8 years in clinical operations

Application instructions:
- Apply now.