Global Director, Clinical Operations | Remote

Astellas Pharma; Northbrook (IL); Hybrid; USD 170,000 - 244,000; Full time

Job summary

Astellas Pharma is seeking a senior Clinical Operations leader based in Northbrook, IL, with global responsibility for oversight of pre/post-POC interventional programs and budgets. You will guide cross-functional teams across regulatory, trial execution, and development planning to ensure timely, high-quality outcomes.

The role requires strong leadership, extensive experience across development phases, and travel ~25%.

Qualifications

• BA/BS degree with at least 12 years of executing complex global drug development programs and trials.
• Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives.
• Must have strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
• Demonstrated ability to successfully identify and lead global process or system improvement initiatives.
• Must have a strong knowledge of clinical development processes and conducting global clinical programs.
• Must have experience working across multiple phases of development and in multiple therapeutic areas.
• Must have proven leadership skills and effective written and verbal communication skills.
• Fluent in English.
• Moderate (~25%) travel required, depending upon assigned program and phase.

Responsibilities

• Oversee and execute Clinical Development Plans and pre/post-POC trials for assigned assets and due diligence projects.
• Provide expert clinical operations strategy input to Asset Teams.
• Develop clinical program budgets and resource estimates.
• Oversee budgets and resources during trial execution.
• Guide extended team members to deliver program milestones on time and with quality.
• Interact with regulatory authorities and key opinion leaders as applicable.
• Facilitate cross-functional collaboration to mitigate risks and ensure timely trial completion.
• Collaborate across Early and Late-Stage Clinical Operations to support asset transitions.
• Drive problem solving and adoption of best practices in clinical operations.

Skills

Leadership

GCP knowledge

Clinical development

Cross-functional collaboration

Communication skills

Fluent English

Education

BA/BS degree

Advanced degree

Job description

Astellas Pharma is seeking a senior Clinical Operations leader based in Northbrook, IL, with global responsibility for oversight of pre/post-POC interventional programs and budgets. You will guide cross-functional teams across regulatory, trial execution, and development planning to ensure timely, high-quality outcomes.

The role requires strong leadership, extensive experience across development phases, and travel ~25%.