Note: The job is a remote job and is open to candidates in USA. Catalyst Pharmaceuticals, Inc. is a pharmaceutical company focused on clinical development and rare disease therapies. The Sr. Director, Clinical Operations provides strategic and operational leadership for the company’s clinical development portfolio, overseeing end-to-end trial execution, portfolio planning, budgets, CROs, compliance, and operational risk. The role also leads cross-functional collaboration, organizational development, continuous improvement, and adoption of innovative clinical trial technologies.
Responsibilities
- Define and execute the Clinical Operations strategy aligned with the overall clinical development plan, ensuring optimal program design, feasibility, and execution across all phases of development
- Lead portfolio-level planning, including resource allocation, capacity forecasting, and budget oversight 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
- Lead vendor and CRO strategy, including selection, contracting, governance, and performance oversight, ensuring high-quality, 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, quality, and patient-centricity
- Provide executive oversight of all clinical trial activities, ensuring delivery of studies on time, within 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 resolution and delivery outcomes
- Oversee end-to-end trial execution, including protocol input, study start-up, site feasibility and selection, activation, enrollment, monitoring, database lock, and close-out for both in-house and outsourced studies
- Serve as the primary escalation point and executive sponsor for clinical programs, ensuring clear decision-making, issue resolution, and alignment across internal and external stakeholders
- Ensure continuous inspection readiness across all studies, with adherence to GCP, SOPs, and global regulatory requirements
- Oversee the development, implementation, and continuous improvement of Clinical Operations processes, systems, and SOPs to support scalable, high-quality execution
- Lead audit and inspection preparedness and response, ensuring timely and effective resolution 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-quality program execution
- Serve as a key interface with executive leadership, providing clear, data-driven updates on program status, risks, and strategic considerations
- Foster strong collaboration with external partners, including CROs, vendors, and alliance partners, ensuring alignment, accountability, and performance excellence
- Build, lead, and develop a high-performing Clinical Operations organization, including recruitment, coaching, performance management, and succession planning
- Establish a culture of accountability, operational excellence, and continuous improvement, empowering teams to deliver high-quality results across multiple concurrent programs
- Drive organizational capability building, including adoption of best practices, tools, and training to support evolving clinical development needs
- Lead continuous improvement initiatives to enhance efficiency, quality, and scalability of clinical operations
- Leverage data, metrics, and analytics to inform decision-making, monitor performance, and drive proactive interventions
- Advance the adoption of innovative technologies and digital solutions to modernize 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
- Minimum 10 years of experience in pharmaceutical industry with at least 5 years of hands-on managerial experience running clinical trials and managing teams
- Therapeutic experience in the areas of Neurology, or Rare/Orphan Disease required
- Experience in the conduct of hospital or clinic-based clinical research trials
- Demonstrated experience leading Clinical Operations to deliver on-time, on-budget high quality outcomes supporting the Clinical Development portfolio
- Excellent written and oral English communication and presentation skills with excellent professional demeanor and presence
- 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
- Strong MS Office Skills
- Excellent analytical and organizational skills; able to set priorities and meet deadlines
- Ability to work effectively on a team in an entrepreneurial environment with proven ability to forge 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, able 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 when necessary
- M.B.A. or advanced degree preferred
- Rare disease experience preferred
- Knowledge of rare disease research guidelines is preferred
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Generous paid time off
- A retirement savings plan with Company Match
Company Overview