Director, Clinical Trial Strategy – Optimization
Job Description:
- Identify opportunities to optimize clinical trial processes across the study lifecycle and drive process changes that improve speed, quality, consistency, and operational efficiency.
- Lead cross-functional teams in the design, implementation, and sustainment of process improvements that support high-quality and timely clinical trial delivery.
- 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.
- Assess current-state workflows, identify root causes of inefficiencies, and prioritize improvement initiatives based on business impact, feasibility, and alignment with strategic goals.
- Develop and monitor key performance indicators, dashboards, and reporting to track process improvement outcomes, risks, and opportunities across clinical trial operations.
- Report progress, insights, and recommendations to executive leadership, providing clear updates on strategic initiatives, implementation status, and measurable impact.
- Establish governance, documentation, and standard work to support consistent execution of updated processes and promote a culture of continuous improvement.
- Build strong partnerships across clinical, operational, quality, technology, and site teams to align stakeholders, remove barriers, and deliver changes to process.
- Collaborate with sites, sponsors, contract research organizations, and vendors as needed to support process alignment, operational readiness, and successful implementation of change.
- Ensure process improvements are implemented in alignment with quality standards, regulatory requirements, and organizational priorities while maintaining focus on sustainable execution.
Requirements:
- Bachelor's Degree required
- 5+ years of experience in clinical trials is required
- Change and program management experience required
- Knowledge of scientific, medical, and regulatory terms
- Knowledge of ICH Guidelines, GCP, and CFR Title 21
- Clinical research process knowledge with an understanding of medical terminology
- Sophisticated problem-solving skills
- Highly organized
- Flexible and adaptable
- Strong communication skills; persuasive, encouraging, motivating, and inspiring; the ability to listen and understand; the ability to communicate the complex in simple terms
- Ability to establish relationships - develop strategic relationships within and outside of direct organization
- Facilitation and communication skills - able to drive plans, decisions, and resolve issues through facilitation of groups or individuals
- Process improvement skills and techniques
- Change management skills and techniques
- Excellent active listening skills
- Experience working in a matrix environment and with virtual team members / stakeholders
- Ability to thrive in team environments of considerable change
- Ability to define vision and lead through change
- Ability to partner with individuals at all levels of management and across organization boundaries
- Ability to work across many teams to identify business opportunities and drive to consensus
Benefits:
- Total Rewards package
- Comprehensive benefits to support physical, mental, and financial well-being