Role Description
The Director, Clinical Trial Strategy & Optimization is responsible for leading efforts to streamline and enhance clinical trial processes to accelerate study delivery while improving quality, consistency, and operational effectiveness. This role drives critical strategic initiatives across the clinical trial lifecycle, identifies opportunities for process improvement, and partners closely with cross-functional teams to implement scalable solutions that support business goals and high-quality trial execution.
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Identify opportunities to optimize clinical trial processes across the study lifecycle and drive process changes that improve speed, quality, consistency, and operational efficiency.
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Lead cross-functional teams in the design, implementation, and sustainment of process improvements that support high-quality and timely clinical trial delivery.
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Ensure site perspectives are represented in process redesign efforts and partner with site stakeholders to bring them along through change planning, communication, training, and adoption.
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Assess current-state workflows, identify root causes of inefficiencies, and prioritize improvement initiatives based on business impact, feasibility, and alignment with strategic goals.
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Develop and monitor key performance indicators, dashboards, and reporting to track process improvement outcomes, risks, and opportunities across clinical trial operations.
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Report progress, insights, and recommendations to executive leadership, providing clear updates on strategic initiatives, implementation status, and measurable impact.
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Establish governance, documentation, and standard work to support consistent execution of updated processes and promote a culture of continuous improvement.
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Build strong partnerships across clinical, operational, quality, technology, and site teams to align stakeholders, remove barriers, and deliver changes to process.
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Collaborate with sites, sponsors, contract research organizations, and vendors as needed to support process alignment, operational readiness, and successful implementation of change.
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Ensure process improvements are implemented in alignment with quality standards, regulatory requirements, and organizational priorities while maintaining focus on sustainable execution.
Qualifications
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Bachelor's Degree required
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At least 5 years of experience in clinical trials is required
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Knowledge of scientific, medical, and regulatory terms
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Knowledge of ICH Guidelines, GCP, and CFR Title 21
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Clinical research process knowledge with an understanding of medical terminology
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Sophisticated problem-solving skills
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Highly organized
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Flexible and adaptable
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Strong communication skills; persuasive, encouraging, motivating, and inspiring; the ability to listen and understand; the ability to communicate the complex in simple terms
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Ability to establish relationships - develop strategic relationships within and outside of direct organization
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Facilitation and communication skills - able to drive plans, decisions, and resolve issues through facilitation of groups or individuals
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Process improvement skills and techniques
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Change management skills and techniques
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Excellent active listening skills
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Experience working in a matrix environment and with virtual team members / stakeholders
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Ability to thrive in team environments of considerable change
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Ability to define vision and lead through change
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Ability to partner with individuals at all levels of management and across organization boundaries
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Ability to work across many teams to identify business opportunities and drive to consensus
Requirements
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This is a remote position based in the United States.
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Relocation and visa sponsorship are not available.
Benefits
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Comprehensive benefits to support physical, mental, and financial well-being.
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Competitive compensation package determined by performance, experience, skills, equity, regular job market evaluations, and geographical markets.
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Other compensation, such as an annual bonus or long-term incentive opportunities may be offered.