Vice President, Clinical Trial Excellence

Responsibilities

• Lead the Clinical Operations Excellence team, overseeing TMF, Clinical Compliance, Monitoring, and Clinical Business Operations.
• Drive strategic outsourcing, alliance management, and financial planning.
• Communicate Clinical Operations Excellence initiatives to cross-functional teams and company leadership.
• Set measurable goals and establish plans to achieve them, focusing on optimization and excellence.
• Harmonize trial operations across the portfolio, ensuring global regulatory compliance.
• Build and maintain strong relationships with CROs, vendors, and external partners.
• Oversee Clinical Operations financials, including accruals and quarterly forecasting.
• Implement technology solutions to enhance clinical workflows and operational efficiency.
• Lead trial diversity, equity, and inclusion initiatives to support diverse patient enrollment.
• Guide the Clinical Operations leadership team through growth, system build, and change management.

Qualifications

• Minimum 20 years of pharmaceutical/biotech industry experience in Clinical Operations.
• Bachelor’s degree required; advanced degree in life sciences, healthcare, or related field (MSc, MBA, PhD, or equivalent) strongly preferred.
• Minimum 10 years of team leadership experience with a proven track record of building effective teams and driving innovation in clinical trial optimization.
• Deep understanding of drug development processes, ICH-GCP guidelines, and major Health Authority regulations.
• Strong leadership, project management, and interpersonal skills with experience in team building and innovation.
• Ability to analyze complex data and distill it into concise executive summaries supported by strong business analysis.
• Availability to participate in international calls and travel 25-30%.