Clinical Study Startup Manager Jobs in Raleigh, NC

We are seeking an accomplishedClinical Project Management Directorto join our Customer-Dedicated Delivery Unit, leading complex global oncology programs and partnering with senior sponsor stakeholders to shape the future of cancer research. This is a highly strategic leadership role offering the opportunity to influence development strategy, drive operational excellence, and oversee the successful execution of innovative clinical studies that have the potential to transform patient outcomes.

The ideal candidate will bring deep oncology expertise, including significant experience leading complex global oncology studies and programs. Experience in Cell & Gene Therapy (CGT), including CAR-T, gene editing, or other advanced therapies, is strongly preferred.

As a trusted partner to our customers, you will lead high-profile programs, guide cross-functional teams, and shape operational strategy across some of the industry's most innovative clinical development initiatives. This role offers the opportunity to work at the forefront of oncology innovation, supporting studies across established and emerging therapeutic modalities, including Cell & Gene Therapy.

What You'll Do

• Strategic Project & Program Leadership: Lead the delivery of large, complex global clinical studies and multi-study programs, translating customer objectives into effective operational strategies and execution plans

• Portfolio Oversight: Provide operational leadership across programs and portfolios, ensuring consistency, quality, financial performance, and successful delivery of clinical milestones

• Customer Partnership: Serve as the primary senior contact for sponsors, building trusted relationships, managing escalations, and driving collaborative solutions to achieve shared goals

• Cross-Functional Leadership: Lead and align global, matrixed teams across clinical operations, data management, safety, regulatory, and other functional areas to ensure seamless execution

• Risk Management & Problem Solving: Proactively identify operational and strategic risks, implement mitigation plans, and lead issue resolution efforts to maintain project momentum and performance

• Financial Accountability: Oversee program financial performance, resource planning, forecasting, scope management, and change control activities to support successful business outcomes

• Business Development Support: Contribute to proposal development, strategic planning, and bid defense activities for large, multi-service clinical opportunities

• Continuous Improvement: Drive innovation, process optimization, and the implementation of best practices to enhance delivery efficiency, quality, and customer satisfaction

• Team Development: Mentor and develop project leaders and cross-functional team members, fostering a culture of accountability, collaboration, and professional growth

What We're Looking For

• 12-15+ years of experience in clinical research, clinical operations, and/or project leadership within the pharmaceutical, biotechnology, or CRO industry, including substantial experience leading large, global Phase I-IV oncology studies and development programs

• Deep oncology therapeutic expertise is required, with a strong preference for experience leading Cell & Gene Therapy (CGT), CAR-T, TCR-T, gene editing or other Advanced Therapy Medicinal Product (ATMP) programs

• Demonstrated success leading complex global oncology portfolios and building trusted relationships with executive-level stakeholders

• Proven success leading large, global, multi-regional clinical studies, programs, or portfolios with operational and financial responsibility

• Strong understanding of clinical trial conduct, ICH-GCP guidelines and applicable regulatory requirements

• Demonstrated ability to build and maintain executive-level customer relationships and successfully manage complex stakeholder environments

• Experience leading matrixed, cross-functional teams in a global environment

• Strong strategic thinking, problem-solving and risk management capabilities

• Excellent communication, presentation and influencing skills

• Bachelor's degree in Life Sciences or a related field required; advanced degree preferred

Leadership Profile

• Influential oncology leader with deep therapeutic expertise and the ability to shape strategy, build trust, and drive alignment across customers, executives and global teams

• Strategic thinker who transforms complex challenges into clear, actionable solutions

• Confident decision-maker who thrives in fast-paced, highly matrixed environments

• Commercially savvy with a strong customer focus and a track record of building enduring partnerships

• Proven leader of large-scale global clinical programs, delivering operational, financial and quality excellence

• Passionate people leader who develops talent, inspires high performance and builds accountable, high-performing teams