Senior Director, Regional Clinical Study Management in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Regional Clinical Study Management based in the United States.

This is a senior leadership opportunity within global clinical operations, responsible for driving the successful execution of complex clinical study portfolios across multiple regions. The role combines strategic oversight, operational excellence, and people leadership within a fast-paced oncology-focused environment. You will guide regional clinical study teams from feasibility through study closeout, ensuring high-quality delivery, inspection readiness, and alignment with global timelines and budgets. Working closely with cross-functional stakeholders including medical affairs, regulatory, data management, and supply chain teams, you will play a key role in shaping study strategy and execution. This position requires strong leadership presence, deep clinical operations expertise, and the ability to influence across a matrixed global organization while fostering a culture of collaboration, accountability, and continuous improvement.

• Provide regional leadership for clinical study management teams, ensuring effective execution of assigned study portfolios across all phases from feasibility to closeout.
• Oversee study delivery to ensure adherence to timelines, budget, quality standards, and regulatory requirements, including ICH/GCP compliance and inspection readiness.
• Lead and mentor regional clinical study managers, fostering high performance, professional development, and strong team engagement.
• Act as escalation point for complex issues, driving resolution and ensuring alignment across regional and global stakeholders.
• Collaborate with global clinical operations, medical affairs, regulatory, biometrics, and supply chain teams to ensure seamless study execution.
• Drive regional study planning, including feasibility assessments, country and site selection, recruitment strategies, and operational alignment.
• Ensure robust oversight of data quality, study metrics, and operational performance, promoting timely data entry and query resolution.
• Contribute to study start-up, execution, and closeout planning, including clinical study report inputs when required.
• Oversee vendor relationships and support strategic resource and budget planning in collaboration with operational partners.
• Develop and refine regional processes, SOPs, and best practices to improve efficiency and consistency across clinical study operations.
• Promote a culture of continuous improvement, cross-functional collaboration, and knowledge sharing across teams and regions.
• Support organizational strategy by contributing to resource planning, performance management, and leadership development initiatives.

• Bachelor’s degree in a scientific, healthcare, or related discipline required; Master’s degree preferred.
• Minimum of 12+ years of progressive experience in clinical operations within biotech, pharmaceutical, or CRO environments, or 8+ years with advanced degree.
• Extensive experience leading clinical study teams and managing complex, multi-regional clinical trials.
• Strong expertise in clinical study lifecycle management, including feasibility, start-up, execution, and closeout phases.
• Deep understanding of clinical trial regulations, including ICH-GCP, and requirements for inspection readiness and compliance.
• Proven leadership experience managing and developing teams in a matrixed, global environment.
• Strong stakeholder management skills with the ability to influence senior leaders and cross-functional partners.
• Excellent analytical, problem-solving, and decision-making abilities in complex operational environments.
• Strong communication and executive presence with the ability to clearly articulate strategy and progress.
• Experience in oncology or other complex therapeutic areas is highly desirable.
• Proficiency in clinical operations tools, reporting systems, and Microsoft Office applications.
• Ability to manage competing priorities in a fast-paced, results-driven environment.
• Willingness to travel as required to support regional and global clinical activities.

• Competitive annual salary ranging from $206,200 to $276,200, depending on experience, qualifications, and location.
• Eligibility for annual bonus and performance-based incentive programs.
• Equity participation opportunities through discretionary stock awards and employee stock purchase plans.
• Comprehensive healthcare coverage including medical, dental, and vision insurance.
• Retirement savings plan (401k) and financial wellness programs.
• Generous paid time off and flexible work arrangements where applicable.
• Wellness programs and employee support initiatives.
• Opportunity to work in a global, science-driven organization focused on advancing oncology treatments.
• Career development, leadership growth, and continuous learning opportunities.
• Inclusive, collaborative culture emphasizing innovation, accountability, and patient impact.