Regional Operations Sr. Director

Job Description

The Regional Operations Head (ROH) acts as Chief of Staff to the Regional Head GCTO Region (RRD) providing end-to-end business and portfolio oversight to ensure performance quality and compliance across regional programs and protocols. The Regional Operations Head plays a critical role in supporting strategy development with the RRD and regional leadership team to drive high performance aligned with strategic and operational goals.

Key Responsibilities:

• Chief of Staff & Portfolio Oversight

• Support the RRD and GCTO Region by facilitating cross-functional meetings to align teams on project goals timelines and deliverables.

• Prepare dashboards status reports and materials to communicate progress risks and issues to leadership.

• Act as liaison between RRD Clinical Research Directors (CRDs) regional teams and key stakeholders including Research Labs and Human Health (HH) to clarify priorities resolve conflicts and ensure alignment on critical GCTO issues.

• Track key milestones dependencies and resource gaps proactively identifying risks and driving follow-up actions to ensure accountability and timely execution.

• Develop and manage the regional project portfolio tracking realization goals and using data to analyze and propose mitigation strategies.

• Identify inefficiencies and propose process improvements to enhance operational effectiveness.

• Regional Trial Allocation & Clinical Research Strategy

• Oversee regional clinical trial allocation coordinating allocation proposals and engaging stakeholders across functions to build a comprehensive knowledge base at capability therapeutic area scientific and strategic levels.

• Collaborate with GCTO regional/country leadership and other key stakeholders in region to develop and align clinical research strategies with long-term regional and corporate objectives.

• Partner with regional support roles to define track and align performance metrics and quality standards in project management operations.

• Work closely with the Regional Operations Support Lead (ROSL) to understand capacity needs and integrate them into country allocation discussions.

• Provide guidance to project management teams on developing and implementing regional processes and tools.

• Issue Escalation & Trend Analysis

• Lead regional issue escalation and conduct trend analysis to identify operational challenges across studies and therapeutic areas.

• Facilitate resolution and action plans in coordination with HQ CRDs and delegates serving as a sentinel for operational risks.

• Foster cultural diversity awareness and address cross-country business needs in regional interactions.

• Strategic Leadership & Collaboration

• Contribute to defining and executing regional priorities to ensure successful delivery across countries.

• Provide deep insights into operational strategy functional areas and networks that enable effective execution.

• Share best practices seek improvement opportunities and drive alignment across GCTO.

• Line Management

• Lead and manage the regional team including the Regional Operations Lead (ROL) Regional Operations Support Lead (ROSL) and Regional Operations Analyst (ROA).

Education:

• Required: Bachelors degree in life science discipline.

• Preferred: Advanced graduate degree (e.g. Masters in life sciences or PhD PharmD). Business and Financial Management (e.g. MBA) advantage.

Required Experience and Skills:

• Clinical Operations Experience: Minimum 10 years of experience in clinical operations preferably within a Sponsor environment managing studies in different therapeutic areas phases from study initiation through completion. Understanding of inspection readiness.

• Leadership: Strong leadership skills to align teams with the goals and mission of our company Global Clinical Development (GCD) and GCTO. Demonstrated success in building and maintaining networks. Ability to communicate effectively with stakeholders to work independently as well as strong business and financial acumen. Willingness to take accountability for actions and to drive results within region.

• Regulatory Knowledge: Comprehensive understanding of ICH GCP guidelines and global regional and local regulatory requirements.

• Communication Skills: Excellent written and verbal communication skills in English with the ability to communicate effectively and professionally at all levels. Additional Language Skills: Proficiency in local languages is advantageous but not mandatory.

Required Skills:

Preferred Skills:

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