Sr. Director, Clinical Operations

Description The Sr. Director Clinical Operations provides strategic and operational leadership for the end-to-end execution of the company’s clinical development portfolio. This role is accountable for designing, implementing, and continuously optimizing Clinical Operations strategies to ensure successful delivery of clinical trials across all phases on time, within budget, and in full compliance with global regulatory and quality standards. Reporting to the SVP., Clinical Development, this leader serves as a key member of the Development Leadership Team, translating clinical strategy into executable, high-impact operational plans. This individual oversees all aspects of clinical trial execution, including bid processes, study start-up, site activation, enrollment, monitoring, database lock, and study closeout, while maintaining continuous inspection readiness and adherence to ICH/GCP and applicable regulatory requirements. The role requires enterprise-level oversight of clinical programs, including leadership of high-performing teams, development of scalable operational infrastructure, and strategic management of CROs and external partners. A strong emphasis is placed on data-driven, risk-based trial management, leveraging analytics, digital tools, and innovative methodologies such as decentralized and hybrid trial models. Description The Sr. Director Clinical Operations provides strategic and operational leadership for the end-to-end execution of the company’s clinical development portfolio. This role is accountable for designing, implementing, and continuously optimizing Clinical Operations strategies to ensure successful delivery of clinical trials across all phases on time, within budget, and in full compliance with global regulatory and quality standards. Reporting to the SVP., Clinical Development, this leader serves as a key member of the Development Leadership Team, translating clinical strategy into executable, high-impact operational plans. This individual oversees all aspects of clinical trial execution, including bid processes, study start-up, site activation, enrollment, monitoring, database lock, and study closeout, while maintaining continuous inspection readiness and adherence to ICH/GCP and applicable regulatory requirements. The role requires enterprise-level oversight of clinical programs, including leadership of high-performing teams, development of scalable operational infrastructure, and strategic management of CROs and external partners. A strong emphasis is placed on data-driven, risk-based trial management, leveraging analytics, digital tools, and innovative methodologies such as decentralized and hybrid trial models. The Sr. Director, Clinical Operations is also responsible for proactive portfolio planning, resource allocation, and budget management across programs, ensuring alignment with corporate objectives and development timelines. As the primary escalation point for operational risks, this leader drives cross-functional collaboration across Clinical Development, Regulatory, Biostatistics, Data Management, and external stakeholders. Additionally, the role shapes the future of clinical operations by advancing process standardization, continuous improvement, and adoption of emerging technologies, while fostering a culture of accountability, operational excellence, and innovation. Requirements Responsibilities (including but not limited to) : Strategic Leadership & Portfolio Planning 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 Operational Execution & Delivery Excellence 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 Quality, Compliance & Inspection Readiness 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 Cross-Functional Leadership & Stakeholder Engagement 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 People Leadership & Organizational Development 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 Operational Excellence & Innovation 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 Education/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 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. Knowledge of rare disease research guidelines is preferred 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 Catalyst is committed to providing competitive wages and comprehensive benefits including health, dental, and vision insurance, generous paid time off, a retirement savings plan with Company Match, and more. Further details about our benefits package can be found here: The base salary for this position will range from $290,000 to $318,000. Candidate experience, professional licensing, and geographic location will be taken into consideration EEO Statement Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status. Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources. #J-18808-Ljbffr