Director of Clinical Ops Program Strategy & Delivery

Biogen; North Carolina; On-site; USD 230,000 - 330,000; Full time

Job summary

Biogen is seeking a Director, Clinical Operations Program Leadership to drive strategy, planning and execution for clinical development programs within the QSDO organization. The role partners with DAT and PDC to align operational plans with asset strategies and governance milestones.

The incumbent brings deep Biotech/Pharma program operations experience, leads complex programs, and ensures studies meet timelines, quality, and budget expectations while coordinating with CROs, vendors and

Qualifications

• Undergraduate degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience preferred.
• Minimum of 12 years' Biotech/Pharma experience in drug development, clinical research and operational strategy.
• Demonstration of project/program management skills including risk assessment and mitigation, timeline and budget management.

Responsibilities

• Leads development and ongoing refinement of program level study timelines and scenarios for Integrated Asset Plan and strategic plans.
• Provide rigorous, objective information and recommended actions to support strategic project decisions.
• Takes overall accountability for QSDO delivery of clinical studies within a program with governance timelines and patient recruitment goals.
• Lead COPL input and governance presentations ensuring the operational voice is integrated.
• Engage with Biogen and partner stakeholders to support clinical program execution and escalate vendor delivery issues for risk mitigation.
• Develop and execute a QSDO Program Operational Plan accounting for therapeutic area and long-term development plans.
• May participate in due diligence and review of external CDP and strategy, including timelines and resource plans.

Skills

Project management

Strategic planning

Stakeholder communication

Risk management

Education

BS in science/health

MS/PhD/MBA preferred

Job description

Biogen is seeking a Director, Clinical Operations Program Leadership to drive strategy, planning and execution for clinical development programs within the QSDO organization. The role partners with DAT and PDC to align operational plans with asset strategies and governance milestones.

The incumbent brings deep Biotech/Pharma program operations experience, leads complex programs, and ensures studies meet timelines, quality, and budget expectations while coordinating with CROs, vendors and