Director, Global Clinical Process Management Lead

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

📋 Description

• Oversee and facilitate global clinical process management initiatives within GCO.

• Ensure that processes, standards, and procedural documents are effective, uniform, sustainable, and adhere to regulatory guidelines.

• Act as the main GCOE contact for designated GCO processes, SOPs, work instructions, and standards.

• Collaborate with Global Process Owners and Subject Matter Experts to create GCO procedural content.

• Drive process management projects, controlled-document updates, continuous improvement efforts, change management, and implementation strategies.

• Manage document review and approval workflows.

• Provide guidance and evaluate processes from other functions that affect GCO processes and standards.

• Foster collaborations with GCO teams and cross-functional stakeholders.

• Contribute to the strategy and materials for process-related training.

• Serve as a liaison between GCO Regional Heads, regional teams, and the GCPM group.

• Interpret process changes and their practical implications for regional and local teams.

• Gather regional feedback and encourage alignment on the adoption of processes.

• Raise regional issues and suggestions to the Head of GCPM and the relevant GCPM Process Lead.

• Evaluate the potential impacts of local and regional regulatory or operational changes on global processes.

• Mentor selected Associate Directors within GCPM.

⛳️ Requirements

• Proficiency in English (both spoken and written).

• A relevant bachelor's degree is required; a degree in a science or healthcare discipline is preferred.

• At least 8 years of experience in the pharmaceutical and/or biotechnology industry.

• Comprehensive understanding of clinical operations processes, ICH-GCP, and compliance management.

• Familiarity with clinical trial regulations.

• Experience in the design, harmonization/optimization, and implementation of clinical trial processes.

• Experience working in a matrix environment and collaborating with global teams.

• Exceptional interpersonal, problem-solving, negotiation, and conflict-resolution abilities.

• Strong organizational skills with a focus on quality management and process enhancement.

• Effective oral and written communication skills.

• Proficient presentation skills.

🏝️ 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.

• Paid Time Off.

• Wellness programs.