Director, Program Operations Leader- Internal Medicine

Role Summary

The Director, Program Operations Leader (Internal Medicine) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This role oversees 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 SOPs within assigned programs. The POL serves on the Clinical Trial Management extended leadership team, managing clinical trial management staff and driving the functional strategy of CTM in partnership with Functional leadership. The Director POL operates with autonomy and a high degree of independence.

Responsibilities

• Be responsible for the overall success of the clinical study team(s) within a program(s)
• Maintain an overview of clinical program status and proactively communicate progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested
• Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
• Oversee clinical study timelines within a clinical program(s)
• Provide input and operational insight into Clinical Study Concepts (CSC)
• Develop and implement 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; ensure consistency within the program and development of best practices within CTM
• Oversee clinical study budgets within a program: ensure review, presentation and approval of initial study budget and manage the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
• Ensure timely delivery of quality operational deliverables and maintain consistency of process and approaches across clinical study teams within the clinical program(s)
• Drive decision making and integrate all operational considerations for studies within a clinical program to ensure goals are attainable prior to implementation
• Act as point of contact for clinical program and study level escalation
• Review key metrics and KPIs across studies and within clinical program(s) to track study progress
• Provide proactive creation and implementation of risk mitigation strategies
• Provide innovative and flexible operational solutions and options to cross-functional and development teams; assist in preparing scenarios for creative solutions to operational challenges
• Drive the strategy and oversight for vendor selection and management within a clinical program
• Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationships with key CRO and vendor counterparts
• May require up to 25% travel

Qualifications

• Required: Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations

Skills

• Operational strategy development
• Budgeting and financial management for clinical programs
• Program and project management
• Vendor and CRO management
• Risk management and mitigation
• Cross-functional leadership and stakeholder communication

Education

• Bachelor's degree (required)

Additional Requirements

• On-site requirements vary by location: US on-site 4 days/week with 1 day from home; Uxbridge and Dublin on-site 3 days/week with 2 days from home; fully remote work not possible