Clinical Operations Director of Programs

2 weeks ago

Shanghai, Shanghai, China AbbVie Full time

The Clinical Operations Director of Programs plays a pivotal role in connecting scientific endeavors with operational expertise to bring clinical studies to life. This role serves as a strategic advocate for pipeline assets, providing operational reality to scientific experiments via scientific expertise, strategic thinking, and innovative solutions to address risks and challenges. The Director is responsible for developing a pipeline of talent for the Development Operations organization and serves as an inspiring people leader.

Key Responsibilities
  • Integral Member of the Pipeline Commercialization Model's Integrated Evidence Strategy Team: Collaborates with cross-functional teams to maximize the value of assets and portfolio for patients and AbbVie.
  • Develops Clinical Operational Strategy: Aligns with asset strategy, incorporating science and operations to execute clinical studies/programs (e.g., generating operational timelines, enrollment options, assessing patient population availability, balancing trial design complexity vs. speed).
  • Risk Evaluation and Mitigation: Proactively identifies and mitigates risks to achieving asset strategy, providing strategic options for the Asset Strategy Team to evaluate in the face of competing priorities, interests, or unanticipated challenges.
  • Collaboration and Influence: Interacts with and influences all levels of management and cross-functional team members to achieve program objectives, primarily within Development Operations, cross-functional colleagues, and Development and Global Medical Affairs Therapeutic Area MDs/SDs.
  • Portfolio Planning: Contributes to portfolio planning, responsible for developing costs, resource projections, and timelines for clinical development programs under consideration.
  • Clinical Operations Content: Reviews and provides clinical operations content to clinical and regulatory documents (e.g., INDs, IB, NDAs, BLAs, MAA, Regulatory Briefing Books).
  • External Budget Management: Responsible for overall external budget management across their portfolio (programs can be 20-200 million dollars).
  • Change Management and Leadership: Leads large scoped, cross-functional innovation and process improvement initiatives with significant business impacts, ensuring effective change management across the cross-functional areas that support clinical program execution.
  • Talent Development and Management: Develops, manages, mentors clinical operations (direct and indirect) staff to enable growth into leadership roles, including strategic leadership and direct supervision of 4 – 15 study managers and up to 30 indirect staff.
  • Compliance and Quality: Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).

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