Director, GCO Clinical Program Lead

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

📋 Description

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

• Act as a primary point of escalation for issues related to studies and compounds.

• Provide strategic guidance to global Clinical Study Managers.

• Recruit, develop, retain, train, mentor, and lead global gCSM teams.

• Supervise project delivery, objectives, budgets, timelines, quality, and operational KPIs.

• Work collaboratively with GCPLs, Franchise Heads, governance teams, and cross-functional R&D leaders on program strategy and implementation.

• Represent GCO in program governance while offering clinical operational insights.

• Lead or engage in KOL interaction activities and serve as a spokesperson for the function when necessary.

• Assess strategic feasibility and budget estimates during initial planning and changes in strategy.

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

• Develop annual program budgets and resource forecasts while monitoring DCT objectives.

• Create, review, maintain, and provide feedback on compound-level documentation such as IB, DSUR, and protocols.

• Conduct regular program review meetings and ensure studies adhere to approved budgets and timelines.

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

• Assess preferred global vendors and participate in vendor governance discussions.

• Create and evaluate performance and development plans for direct reports.

• Offer line management and mentorship to gCSMs.

• Promote scientific knowledge development and process enhancement throughout Clinical Operations.

• Utilize ICH/GCP and regulatory expertise in the execution of clinical trials.

⛳️ Requirements

• Bachelor's degree or higher in a scientific or healthcare field.

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

• Profound expertise in therapeutic areas.

• Skills in global program management and a comprehensive global perspective.

• Experience in project management across the entire lifecycle of multi-region/country clinical trials.

• Background in a fast-paced global environment.

• Preferred experience in people management and program management.

• Familiarity with ICH/GCP Guidelines and relevant regulatory requirements.

• Proficient in MS Office applications.

• Experience with project planning software.

• Familiarity with Clinical Trial Management Systems (CTMS).

• Willingness to travel domestically and internationally, up to 20%.

• Ability to collaborate with colleagues across different time zones.

🏝️ Benefits

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

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life insurance coverage.

• Paid time off.

• Wellness benefits.

• Equal opportunity employer.

• Reasonable accommodations during the job application process.