Executive Director of Operations - CRO

Clinovo; United States; On-site; USD 180,000 - 280,000; Full time

Job summary

Clinovo is seeking an Executive Director of Clinical Operations & Development to lead global trial activities, oversee sponsor and site-level research infrastructure, and partner with CROs and vendors. The role focuses on oncology development, operational excellence, and technology-enabled clinical research solutions.

The candidate will direct global project management teams, drive SOPs, and ensure compliance with ICH-GCP across multiple regions, while collaborating with internal leadership and

Qualifications

• Extensive experience leading global clinical operations in sponsor/CRO settings.
• Deep expertise in oncology drug development.
• Strong leadership of cross-functional teams and vendors.
• Knowledge of global regulations (ICH-GCP).

Responsibilities

• Provide strategic and operational leadership for global clinical trial activities.
• Oversee sponsor and investigative site level research infrastructure.
• Lead cross-functional teams and global project management personnel.
• Ensure compliance with ICH-GCP and regulatory requirements.
• Manage budgets, timelines, resources, and operational performance.
• Develop SOPs, policies, and processes to support quality and regulatory compliance.
• Collaborate with Clinical Development, Data Management, Biostatistics, and other teams to achieve objectives.

Skills

Global leadership

Clinical Operations

Oncology development

Budget & timelines management

Tools

EDC

CTMS

eTMF

RTSM

Job description

We are seeking an experienced Executive Director of Clinical Operations & Development to join a highly innovative and entrepreneurial life sciences organization focused on transforming clinical research through technology, operational efficiency, and data-driven solutions.

This individual will play a critical leadership role in addressing challenges across clinical trial execution, including rising development costs, fragmented data systems, inefficient workflows, and barriers to patient access. The organization is committed to developing and implementing innovative technologies and methodologies that improve clinical trial delivery and accelerate the development of novel therapeutics.

The Executive Director of Clinical Operations & Development will be responsible for leading global clinical trial operations, overseeing clinical research infrastructure at both the sponsor and investigative site levels, and supporting the implementation of technology-enabled clinical research solutions.

This position will work cross-functionally with internal leadership, clinical research teams, external sponsors, CROs, investigative sites, and technology partners to establish operational processes, implement innovative solutions, and optimize clinical trial execution.

The successful candidate will bring extensive experience across sponsor organizations, CROs, and clinical research sites, with a strong background in global clinical operations, oncology drug development, and operational leadership. This role will include oversight of global project management teams and country-level personnel.

Key Responsibilities:

Global Clinical Operations Leadership:

• Provide strategic and operational leadership for global clinical trial activities, ensuring effective execution across multiple countries and regions.
• Oversee clinical trial operations and infrastructure at both the sponsor and investigative site levels.
• Lead cross-functional teams and global project management personnel to ensure successful delivery of clinical development programs.
• Provide expertise in clinical trial compliance with applicable local and international regulations, including ICH-GCP guidelines.
• Oversee clinical trial budgets, timelines, resources, and operational performance.
• Establish and maintain standard operating procedures (SOPs), policies, and operational processes to support quality and regulatory compliance.
• Collaborate with Clinical Development, Clinical Operations, Data Management, Biostatistics, and other functional teams to achieve program objectives.

Technology Implementation & Process Optimization:

• Provide operational expertise supporting the development and implementation of innovative clinical trial technologies across sponsor and site environments.
• Partner with internal teams, external vendors, and clinical research stakeholders to support technology adoption and implementation.
• Identify operational inefficiencies and opportunities to improve clinical trial workflows, data collection, and study execution.
• Contribute to the design and development of technology-enabled solutions, including workflow templates, data capture forms, training materials, and implementation tools.
• Provide recommendations for improvements to clinical research software, systems, and operational processes.
• Support the integration of clinical trial technologies into existing sponsor and site workflows.
• Contribute to the development of innovative solutions that enhance clinical trial efficiency, data quality, and patient access.

Cross-Functional Collaboration & Stakeholder Management:

• Serve as a senior operational representative in discussions with sponsors, CROs, investigative sites, technology vendors, and other external stakeholders.
• Lead problem-solving initiatives and collaborate with internal and external partners to address operational challenges.
• Build and maintain strong relationships across global clinical research teams and external organizations.
• Provide strategic input into business cases, operational proposals, and clinical development initiatives.
• Participate in requests for proposals (RFPs), bid defenses, and other business development activities.
• Influence stakeholders across organizational levels to drive alignment and implementation of operational strategies.
• Support the development and execution of training programs for internal teams and external clinical research stakeholders.

Strategic Leadership & Organizational Development:

• Lead and mentor global clinical operations and project management teams.
• Drive operational excellence through the development of scalable processes, infrastructure, and performance metrics.
• Apply strategic, analytical, and innovative thinking to address complex clinical research challenges.
• Support organizational growth by identifying opportunities to improve operational capabilities and service delivery.
• Collaborate with senior leadership to develop and execute clinical operations strategies aligned with organizational objectives.
• Stay informed of emerging trends, competitive developments, and advancements in clinical research technologies and methodologies.
• Perform additional responsibilities as needed to support business and clinical development objectives.

Required Qualifications:

• Extensive experience in clinical research and drug development, including progressive leadership responsibilities within Clinical Operations and/or Clinical Development.
• Demonstrated experience working across pharmaceutical or biotechnology sponsors, CROs, and investigative clinical research sites.
• Significant experience overseeing global Phase I-III clinical trials, with deep expertise in oncology clinical development.
• Previous hands-on experience in Clinical Research Associate (CRA) and/or Clinical Trial Manager (CTM) roles.
• Proven ability to lead global, cross-functional teams and manage clinical research personnel across multiple countries.
• Strong understanding of the drug development lifecycle, including clinical development, regulatory requirements, and commercialization considerations.
• Demonstrated expertise in clinical trial project management, including study budgets, timelines, resource planning, and vendor oversight.
• Advanced knowledge of clinical operations technologies and systems, including EDC, RTSM, CTMS, and eTMF platforms.
• Strong understanding of the functions and interdependencies of Clinical Operations, Clinical Development, Data Management, and Biostatistics.
• Experience developing and implementing SOPs, operational policies, training programs, and clinical research procedures.
• Experience supporting RFP processes, bid defenses, and strategic business development initiatives.
• Demonstrated ability to operate effectively in a fast-paced, entrepreneurial, and evolving organizational environment.
• Willingness to travel domestically and internationally as required.

Core Competencies:

• Exceptional leadership, communication, negotiation, and interpersonal skills.
• Strong strategic thinking, analytical capabilities, and problem-solving abilities.
• Proven ability to influence stakeholders and build alignment across cross-functional teams.
• Effective conflict resolution skills and a collaborative leadership approach.
• Strong organizational and time management capabilities, with the ability to manage competing priorities.
• Demonstrated ability to work independently while maintaining effective collaboration across global teams.
• Adaptability and comfort operating in dynamic, deadline-driven environments.
• Strong business acumen and the ability to translate operational challenges into actionable solutions.
• Commitment to continuous improvement, innovation, and operational excellence.
• Highest standards of professionalism, accountability, and integrity.