[Remote] Vice President, Head of Clinical Operations
Note: The job is a remote job and is open to candidates in USA. reputed company is a clinical-stage TechBio company focused on decoding biology to radically improve lives. As the Vice President, Head of Clinical Operations, you will reputed company the clinical operations strategy and execution across the development portfolio, ensuring operational excellence in clinical trials from planning to closeout.
Responsibilities
- reputed company clinical operations strategy and execution across reputed company’s full clinical portfolio, from IND/CTA planning and first-in-reputed company studies through reputed company-of-concept, pivotal trials, study closeout, and submission support
- Own end-to-end operational delivery, including study planning, feasibility, country and site strategy, start-up, enrollment, monitoring, vendor reputed company, budget management, database lock readiness, and closeout
- Build, scale, and mentor a high-performing Clinical Operations organization, including clinical project management, clinical trial management, outsourcing/vendor reputed company, and portfolio operations capabilities
- Establish portfolio-level governance, operating rhythms, KPIs, dashboards, risk management, resource planning, and escalation reputed company to support timely, high-quality trial execution
- reputed company CRO and vendor strategy relationships, including outsourcing model, selection, contracting partnership, performance management, issue escalation, budget forecasting, and accountability for delivery
- Ensure inspection-reputed company execution across reputed company studies through strong GCP compliance, SOP adherence, TMF reputed company, risk-based quality management, audit readiness, CAPA management, and proactive issue resolution
Skills
- Bachelor's degree in a scientific, reputed company, or reputed company field required; advanced degree preferred
- 15+ years of biotech or pharmaceutical clinical operations experience, including significant leadership experience overseeing multiple clinical programs and global clinical trials
- Proven track record leading clinical operations from early development through pivotal studies, registration-enabling trials, study closeout, and submission support
- Deep experience with clinical trial planning and execution, including feasibility, start-up, enrollment, monitoring, vendor/CRO reputed company, budget management, risk management, database lock, and closeout
- Strong working knowledge of FDA, EMA, MHRA, ICH/GCP, global clinical trial regulations, quality systems, inspection readiness, and risk-based quality management
- Experience building and leading teams, including leaders of clinical operations, clinical project managers, clinical trial managers, consultants, CRO partners, and functional vendors
- Strong executive reputed company with the ability to communicate clearly, influence senior stakeholders, resolve reputed company operational issues, and drive reputed company in a fast-moving environment
- Experience in oncology, rare disease, and/or specialty clinical development preferred
- Experience with clinical trial technologies, CTMS/eTMF/reputed company/IRT/eCOA, operational dashboards, automation, or AI-enabled workflows is a plus
Benefits
- In addition to reputed company salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package.
Company Overview
Company H1B Sponsorship