SummaryWe are seeking a Global Program Operations Head (GPOH), reporting into the Vice President, Clinical Operations, to lead the strategic and operational execution of a portfolio of clinical trials within a designated disease area. This role partners cross-functionally with Clinical, Medical, Regulatory, and Operational Excellence to ensure programs are aligned with corporate goals, regulatory requirements, and operational feasibility.
You will drive program-level strategy, oversee trial execution, and manage Contract Research Organizations (CROs) and external vendors, ensuring delivery against timelines, budgets, and quality expectations. Additionally, you will lead and develop a high-performing clinical operations team while supporting governance, risk management, and inspection readiness in a fast-paced biotech environment.
Your Role - Oversee the strategic and operational execution of a portfolio of clinical trials within a designated disease area
- Ensure alignment with corporate goals and regulatory standards
- Represent Global Clinical Operations in Global Program Teams (GPTs) and sub-teams, contributing to program-level strategy and operational planning
- Collaborate with Medical and Regulatory Directors to ensure clinical strategies are scientifically sound, meet regulatory requirements, and are operationally feasible
- Partner with Operational Excellence & Clinical Compliance to align on risk assessment, trial- and site management metrics, KPIs, and KRIs
- Define and implement outsourcing strategies in partnership with the VP of Global Clinical Operations and Head of Clinical Sourcing & Contracting
- Lead the selection, negotiation, contracting, and performance oversight of CROs and external vendors
- Monitor trial progress and key deliverables, guiding Clinical Trial Teams (CTTs) in execution planning, issue resolution, and risk mitigation
- Manage program and trial budgets, ensuring accurate forecasting, cost control, and financial accountability
- Track CRO/ vendor performance using metrics, KPIs, KRIs and participate in governance meetings to address escalated issues and drive continuous improvement
- Provide regular updates on trial progress to internal governance bodies, including GPT and Executive Leadership Team
- Support inspection readiness activities and represent the organization during Health Authority inspections
- Provide leadership, coaching, and performance management to Clinical Trial Leaders (CTLs), Clinical Contract Managers (CTMs), Clinical Trial Specialists (CTSs), and Site Management Leader (SMLs)
- Set clear objectives, deliver ongoing feedback, and develop tailored development plans to support team growth and capability building
- Oversee hiring, onboarding, and training of new team members, fostering a culture of operational excellence and continuous learning
What You Bring - 12+ years of trial management experience with 7+ years in leadership position
- Bachelor's degree in Life Sciences, Pharmacy or related field (required). Advanced degree, e.g., MS, PharmD, PhD, MBA (preferred).
- Significant experience working in global clinical development organization
- Experience in Oncology development (preferred)
- Direct experience with health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections
- Significant experience in outsourcing and oversight
- Expert knowledge in ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines
- Expert knowledge in financial planning, tracking, and reporting
- Expert knowledge in risk assessment and management on program and trial-level
- Executive presence and strategic thinking on corporate-, program-, and trial-level
- Strong decision-making and sound judgment
- Strong leadership and interpersonal skills
- High credibility with senior leadership
- Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIs
- Willingness to travel, as required (typically 10-20%)
#LI-Hybrid
Salary range
$225,600-$338,400 USD
