Job Description
```html This role is a hybrid position which requires a minimum of 3 days on-site in Basking Ridge, NJ, Armonk, NY, Uxbridge, UK, or Dublin, IRE. The Program Operations Leader (POL) will lead and implement the operational strategy for the delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines, and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations, and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners, and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring, and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and a high degree of independence. In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s). Maintain an overview of clinical program(s) status and issues and proactively communicate progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to partners as requested. Provide operational insight into feasibility, timeline, and cost estimates during clinical program/study development. Coordinate clinical study timelines within a clinical program(s). Provide input and operational insight into Clinical Study Concepts (CSC). Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol. Review plans and provide clinical operations expertise during protocol design, feasibility, study start-up, and conduct phases of studies. Ensure consistency within the program and development of standard processes within CTM. Lead all aspects of clinical study budgets within a program: ensure review, presentation, and approval of the initial study budget and manage the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate. This job may be for you if you have: Advanced interpersonal & leadership skills. Ability to provide operational strategic direction and guidance for clinical programs. Applies sophisticated technical knowledge to solve highly complex issues. An understanding of relevant industry trends. Strong analytical skills with a data-driven approach to planning, executing, and problem-solving. Advanced interpersonal skills via verbal, written, and presentation abilities. Proactive and self-disciplined with the ability to meet deadlines, effective use of time, and prioritization. Ability to influence and negotiate across a wide range of senior partners (i.e., functional area heads). Budget management expertise and strong financial competence. Consistent track record of building, leading, and developing productive teams and collaborations. Expert project management skills, cross-functional engagement, and organizational skills. To be considered, you must have a Bachelor's degree and a minimum of 12 years relevant in-house sponsor-side pharmaceutical industry experience, with 8 years within Clinical Trial Management. Experience in Internal Medicine is highly preferred (obesity, metabolism, diabetes, cardiovascular). Experience in Phase 4 trials is highly preferred. Previous people management experience required. ``` #J-18808-Ljbffr