Director, GCO Program Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee strategic operational planning and the clinical operational performance for assigned programs.

• Serve as the escalation point for issues related to studies and compounds.

• Lead gCSMs while providing mentorship, talent development, performance management, and resource allocation.

• Collaborate with program leads and functional representatives to advance disease and asset strategies.

• Offer clinical operational insights to governance teams and assist in shaping program strategies.

• Lead or engage in KOL (Key Opinion Leader) interaction activities.

• Assess strategic feasibility and budget projections for new clinical development initiatives and strategy alterations.

• Allocate resources and initiate the formation of CSTs (Clinical Study Teams).

• Develop annual program budgets and resource forecasts.

• Create, review, maintain, and contribute to compound-level documents, including IB, DSUR, and protocols.

• Supervise study planning and execution within the assigned program.

• Conduct program review meetings and monitor studies against approved budgets and timelines.

• Report on study status, objectives, operational KPIs, and quality KPIs.

• Assess preferred global vendors and take part in vendor governance meetings.

• Provide line management and mentorship to gCSMs.

• Promote scientific knowledge advancement and process optimization within Clinical Operations.

• Work in collaboration with cross-functional leaders to support clinical development objectives.

⛳️ Requirements

• Bachelor’s degree or higher in a scientific or healthcare-related field.

• Over 10 years of experience in the clinical trial sector.

• Experience in lung cancer is essential.

• Familiarity with project management across the complete lifecycle of multi-region/country clinical trials in a dynamic global setting.

• People management and program management experience is preferred.

• Proficient in Microsoft Office applications.

• Strong knowledge of ICH/GCP Guidelines and other relevant regulatory standards.

• Expertise in clinical documentation and records management.

• Proven experience in clinical operations management.

• Knowledge of contract management.

• Competence in data management.

• Experience conducting feasibility studies.

• Skills in project/program design.

• Proficient in project/program management.

• Risk management skills.

• Ability to produce technical reports.

• Resource management experience.

• Willingness to travel as required by business needs.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) / Health Savings Account (HSA) options.

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness benefits.