Director, Clinical Operations – Global Program Leadership

Regulatory Jobs; North Carolina; On-site; USD 198,000 - 272,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401(k) plan with company match

Employee stock purchase plan

Paid time off & holidays

Job summary

Biogen seeks a Director, Clinical Operations Program Leadership (COPL) to strategize and execute program-level clinical operations within the QSDO. This role influences Integrated Asset Plans and governance decisions, aligning operational voice with senior leadership.

You will guide timelines, risk management, and cross-functional collaboration with DAT, PDC, CROs, and vendors to ensure timely, compliant delivery across Ph1–Ph4 and potential LCM stages.

Qualifications

• Undergraduate degree in a scientific or health-related discipline; advanced degree preferred.
• 12+ years in Biotech/Pharma with drug development, clinical research and operational strategy, with at least 3 years in a Delivery capacity.
• Demonstration of project/program management skills including risk assessment, timelines, budgets and contingencies.
• Demonstration of effective team leadership and ability to influence matrix teams; excellent communication and problem-solving skills.
• Experience delivering global clinical programs across Ph1-4 and lifecycle management.

Responsibilities

• Leads development of program-level study timelines and scenarios to contribute to IAP and other strategic plans.
• Provide rigorous, objective information and aligned QSDO recommendations to DAT for strategic decisions.
• Owns QSDO delivery of clinical studies within a program, ensuring high quality, cost-efficient timelines and recruitment goals.
• Lead governance materials and presentations, communicating risks to senior leaders.
• Engage with Biogen and partners (CROs, vendors) to support execution and mitigate risks to timelines.
• Develop and execute a QSDO Program Operational Plan (POP) aligned to therapeutic area and science.

Skills

Project management

Team leadership

Communication

Time management

organizational skills

Data-driven timelines

Therapeutic domain knowledge

Operational expertise

CDP development

Education

Undergraduate degree in science/health

Advanced degree preferred (MS/PhD/PharmD/MBA/MPH)

Job description

Biogen seeks a Director, Clinical Operations Program Leadership (COPL) to strategize and execute program-level clinical operations within the QSDO. This role influences Integrated Asset Plans and governance decisions, aligning operational voice with senior leadership.

You will guide timelines, risk management, and cross-functional collaboration with DAT, PDC, CROs, and vendors to ensure timely, compliant delivery across Ph1–Ph4 and potential LCM stages.