Director, Program Operations Leader- Internal Medicine

Role Summary

The Director, Program Operations Leader (Internal Medicine) is responsible for leadership of 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 program(s). The POL is a member of the CTM leadership team, interacts with senior management, external vendors, collaboration partners and clinical study personnel, and is responsible for line management of CTM staff, recruitment, development, coaching, mentoring and performance management. 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 issues, proactively communicating progress, risks, issues or changes that may impact quality, timelines and/or budget; provide 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 CSC through Final Protocol
• Review plans and provide clinical operations expertise during protocol design, feasibility, start-up and conduct phases; promote consistency and best practices within CTM
• Oversee clinical study budgets within a program; review, present and approve initial study budgets and manage budgets through the lifecycle by communicating changes to TA Operations Leader as appropriate
• Ensure timely delivery of quality operational deliverables and maintain consistency of processes across clinical study teams within the program
• Drive decision making and integrate operational considerations to ensure goals are attainable
• Act as point of contact for clinical program and study-level escalation
• Review key metrics and KPIs across studies to track progress
• Provide proactive creation and implementation of risk mitigation strategies
• Provide innovative and flexible operational solutions and options to cross-functional and development teams; prepare scenarios for solutions to operational challenges
• Drive strategy and oversight for vendor selection and management within a clinical program
• Manage the CRO and vendor relationships related to program-level deliverables
• May require up to 25% travel

Qualifications

• Required: Bachelor's degree
• Required: 12+ years of related in-house sponsor-side pharmaceutical experience, with 8+ years in clinical operations
• Travel: up to 25% travel may be required

Skills

• Leadership and people management
• Operational strategy and program management
• Budgeting and financial oversight
• Clinical trial development, start-up, and conduct oversight
• Vendor and CRO management
• Risk assessment and mitigation
• Cross-functional collaboration and stakeholder communication
• Data-driven decision making and KPI analysis

Additional Requirements

• On-site work expectations vary by location (on-site 4 days/week with 1 day remote in US; on-site 3 days/week with 2 days remote for Uxbridge and Dublin) as specified