Strategic Leader - Clinical Operations & Excellence (Remote)

Jobgether; United States; Presencial; USD 219.000 - 329.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote working arrangement

Descripción de la vacante

Jobgether, on behalf of a partner company, seeks a Senior Director, Clinical Operations Business & Excellence in the United States. The role leads a centralized Clinical Operations Business Office, shaping strategy, governance, and standards to support a growing clinical development portfolio.

This senior leadership role will strengthen trial execution with a focus on quality, efficiency, and patient impact.

Formación

• Bachelor's degree in a scientific, business, healthcare, or related discipline; MBA/MS/PhD/PharmD preferred.
• 12+ years in clinical operations or related functions with leadership of complex programs.
• Experience preparing teams for pivotal inspections and sustaining inspection readiness.
• Expertise in CRO/vendor governance, contract negotiations, and investigator site budgeting.
• Ability to establish sourcing and vendor governance strategies and manage partner performance.
• Strong knowledge of eTMF governance and ICH-GCP, risk-based quality management.

Responsabilidades

• Establish and lead the centralized Clinical Operations Business Office with defined operating model and service expectations.
• Oversee roadmap, objectives, metrics, and capacity planning across programs to reduce duplication.
• Oversee vendor governance, master service agreements, SOWs, and contract amendments with Legal and Finance.
• Lead site contracting, budgeting templates, and investigator budget negotiation for consistency.
• Establish portfolio-wide inspection-readiness practices and coordinate audits with Quality.
• Define risk-based quality management and cross-study trend analysis to prevent issues.
• Lead digital enablement via dashboards, analytics, and automation in collaboration with Technology.
• Represent Clinical Operations in senior governance and communicate risks and options to leadership.

Conocimientos

Leadership

Strategic thinking

Communication

Cross-functional collaboration

Vendor governance

eTMF governance

Inspection readiness

Budgeting

Negotiation

Educación

Bachelor's degree or higher in a scientific, business, healthcare, or related discipline

Descripción del empleo

Jobgether, on behalf of a partner company, seeks a Senior Director, Clinical Operations Business & Excellence in the United States. The role leads a centralized Clinical Operations Business Office, shaping strategy, governance, and standards to support a growing clinical development portfolio.

This senior leadership role will strengthen trial execution with a focus on quality, efficiency, and patient impact.