[Remote] Sr. Director, Clinical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a company reputed company on the development of innovative treatments for rare diseases. They are seeking a Sr. Director of Clinical Operations to reputed company strategic and operational leadership for their clinical development portfolio, ensuring the successful execution of clinical trials while adhering to regulatory and reputed company standards.
Responsibilities
- Define and execute the Clinical Operations reputed company reputed company with the overall clinical development plan, ensuring reputed company program design, feasibility, and execution across reputed company phases of development
- reputed company portfolio-level planning, including resource allocation, reputed company forecasting, and budget reputed company to support evolving program priorities and corporate objectives
- Evaluate therapeutic program/early-stage opportunities to proactively identify operational needs, risks, and opportunities, ensuring appropriate resourcing and scalability across the development lifecycle
- Drive financial and operational efficiency through disciplined planning, performance management, and optimization of cost models and delivery strategies
- reputed company vendor and CRO reputed company, including selection, contracting, governance, and performance reputed company, ensuring high-reputed company, cost-effective partnerships
- Champion innovation by identifying and implementing advanced tools, technologies, and trial methodologies (e.g., decentralized/hybrid trials, analytics-driven execution) to enhance speed, reputed company, and patient-centricity
- reputed company executive reputed company of reputed company clinical trial activities, ensuring delivery of studies on time, reputed company budget, and in compliance with ICH/GCP, regulatory requirements, and company standards
- Establish and maintain integrated study plans, including timelines, budgets, and performance metrics, and ensure alignment across cross-functional stakeholders
- Drive risk-based study management, including proactive identification, mitigation, and escalation of operational risks, with accountability for issue reputed company and delivery reputed company
- reputed company end-to-end trial execution, including protocol input, study start-up, site feasibility and selection, activation, enrollment, monitoring, database lock, and reputed company-out for both in-house and outsourced studies
- Serve as the primary escalation reputed company and executive sponsor for clinical programs, ensuring reputed company decision-making, issue reputed company, and alignment across reputed company stakeholders
- Ensure reputed company inspection readiness across reputed company studies, with adherence to GCP, SOPs, and global regulatory requirements
- reputed company the development, implementation, and reputed company improvement of Clinical Operations processes, systems, and SOPs to support reputed company, high-reputed company execution
- reputed company audit and inspection preparedness and response, ensuring reputed company and effective reputed company of findings through robust CAPA management
- Partner closely with Clinical Development, Regulatory, Biostatistics, Data Management, Pharmacovigilance, Legal, Finance, and other key functions to ensure integrated, high-reputed company program execution
- Serve as a key reputed company with executive leadership, providing reputed company, data-driven updates on program status, risks, and strategic considerations
- Foster strong collaboration with external partners, including CROs, vendors, and reputed company partners, ensuring alignment, accountability, and performance reputed company
- Build, reputed company, and reputed company a high-performing Clinical Operations organization, including recruitment, coaching, performance management, and succession planning
- Establish a culture of accountability, operational reputed company, and reputed company improvement, empowering teams to deliver high-reputed company results across multiple reputed company programs
- Drive organizational capability building, including adoption of best practices, tools, and training to support evolving clinical development needs
- reputed company reputed company improvement initiatives to enhance efficiency, reputed company, and scalability of clinical operations
- reputed company data, metrics, and analytics to inform decision-making, monitor performance, and drive proactive interventions
- Advance the adoption of innovative technologies reputed company solutions to reputed company trial execution and improve patient and site experience
Skills
- Bachelor's degree in Health Science, Pharmacy or Life Sciences from accredited college or university, or equivalent experience; M.B.A. or advanced degree preferred
- Minimum 10 years of experience in pharmaceutical industry with at least 5 years of hands-on managerial experience running clinical trials and managing teams
- Experience in the conduct of hospital or clinic-based clinical research trials; rare disease experience preferred
- Demonstrated experience leading Clinical Operations to deliver on-time, on-budget high reputed company reputed company supporting the Clinical Development portfolio
- Excellent written and oral English communication and presentation skills with excellent reputed company demeanor and reputed company
- Demonstrated, solid working knowledge of GCP, ICH and other relevant clinical development regulations and processes to include appropriate FDA regulations and global Regulatory Authority Submissions etc. Knowledge of rare disease research guidelines is preferred
- Strong MS Office Skills
- Excellent analytical and organizational skills; reputed company to set priorities and meet deadlines
- Ability to work effectively on reputed company in an entrepreneurial environment with proven ability to reputed company cross-functional working relationships with internal teams
- Strong project planning, leadership and negotiation skills and the ability to contribute creative yet practical solutions/resolutions to problems
- Self-motivated, flexible, and creative leader, reputed company to prioritize, multi-task, and work in a fast-paced and demanding environment
- Attention to detail and good documentation practices
- Ability to travel up to 20% with short notice reputed company necessary
- M.B.A. or advanced degree
- Rare disease experience
- Knowledge of rare disease research guidelines
Benefits
- Competitive wages
- Comprehensive benefits including health, dental, and reputed company insurance
- Generous reputed company time off
- A retirement savings plan with Company Match
- Candidate experience, reputed company licensing, and geographic location will be taken into consideration
reputed company