[Remote] Vice President, Head of Clinical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage TechBio company reputed company on decoding biology to radically improve lives. As the Vice President, Head of Clinical Operations, you will reputed company the clinical operations reputed company and execution across the development portfolio, ensuring operational reputed company in clinical trials from planning to closeout.
Responsibilities
- reputed company clinical operations reputed company 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 reputed company, start-up, enrollment, monitoring, vendor reputed company, budget management, database lock readiness, and closeout
- Build, reputed company, 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 reputed company, high-reputed company trial execution
- reputed company CRO and vendor reputed company 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 reputed company management, audit readiness, CAPA management, and proactive issue reputed company
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 reputed company 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, reputed company systems, inspection readiness, and risk-based reputed company 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 reputed company, 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 reputed company to reputed company salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package.
reputed company
Company H1B Sponsorship