Senior Director, Global Clinical Operations – Hematology

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver strategic operational planning and enhance clinical operational performance for Hematology franchise programs.

• Serve as the escalation point for resolving program-related challenges.

• Lead and oversee the Global Clinical Program Lead and Global Clinical Study Manager teams.

• Build, develop, and retain the global team, encompassing hiring, training, mentoring, performance evaluations, and resource management.

• Supervise the delivery and achievement of goals for programs and projects within assigned franchises.

• Define and execute strategies, priorities, global standards, performance metrics, and capability enhancement.

• Engage in P&SM decision-making, strategy formulation, functional management, process optimization, and streamlining.

• Represent GCO in governance teams and provide clinical operational insights for Therapeutic/Asset strategy.

• Lead or participate in KOL engagement initiatives and act as a functional spokesperson as needed.

• Assess strategic feasibility and budget projections for new clinical development initiatives and strategic alterations.

• Allocate resources and initiate CST formation.

• Develop annual budget and resource forecasts along with relevant DCT goals.

• Create, review, and maintain compound-level documentation including IB, DSUR, and protocols.

• Guide clinical study teams to ensure timely, high-quality, and efficient study planning and execution.

• Conduct program review meetings while monitoring study budgets and timelines.

• Report on program and study status, objectives, and operational KPIs.

• Collaborate on the selection of global vendors and vendor governance.

• Create or assess performance and development plans for direct reports.

• Provide line management and mentorship.

• Foster scientific knowledge advancement within Clinical Operations.

• Promote a global mindset and collaboration across Clinical Operations.

• Offer expert guidance on clinical trial execution and relevant regulatory requirements.

• Lead initiatives for process improvement.

• Collaborate with cross-functional leaders to achieve clinical development objectives.

⛳️ Requirements

• Bachelor's degree or higher in a scientific or healthcare field.

• Over 12 years of experience in the clinical trial sector.

• Experience in project and program management throughout the entire lifecycle of multi-region/country clinical trials.

• Proven experience in a dynamic global environment.

• Demonstrated outstanding record and achievements in global clinical operations.

• Evidence of strong leadership skills or potential.

• At least 3 years of leadership and people management experience.

• Minimum of 3 years of leadership experience managing senior-manager-level or higher personnel.

• Preference for experience in second-line management.

• 3+ years of experience in Hematology cancers is preferred.

• In-depth understanding of ICH/GCP Guidelines and other applicable regulatory standards.

• Capability to manage direct or indirect reports.

• Global competencies such as teamwork, actionable feedback, self-awareness, inclusivity, initiative, entrepreneurial mindset, continuous learning, adaptability, results orientation, analytical thinking/data analysis, financial excellence, and clear communication.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life Insurance coverage.

• Paid Time Off.

• Wellness program.

• Reasonable accommodation during the job application process.