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Responsibilities
The Sr. Director Clinical Operations provides strategic and operational leadership for the end-to-end execution of the company’s clinical development portfolio.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.Responsibilities (including but not limited to)Strategic Leadership & Portfolio PlanningDefine and execute the Clinical Operations strategy aligned with the overall clinical development plan, ensuring optimal program design, feasibility, and execution across all phases of developmentLead portfolio-level planning, including resource allocation, capacity forecasting, and budget oversight to support evolving program priorities and corporate objectivesEvaluate therapeutic program/early-stage opportunities to proactively identify operational needs, risks, and opportunities, ensuring appropriate resourcing and scalability across the development lifecycleDrive financial and operational efficiency through disciplined planning, performance management, and optimization of cost models and delivery strategiesLead vendor and CRO strategy, including selection, contracting, governance, and performance oversight, ensuring high-quality, cost-effective partnershipsChampion 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-centricityOperational Execution & Delivery ExcellenceProvide executive oversight of all clinical trial activities, ensuring delivery of studies on time, with in compliance with ICH/GCP, regulatory requirements, and company standardsEstablish and maintaluding timelines, budgets, and performance metrics, and ensure alignment across cross-functional stakeholdersDrive risk-based study management, including proactive identification, mitigation, and escalation of operational risks, with accountability for issue resolution and delivery outcomesOversee 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 studiesServe as the primary escalation point and executive sponsor for clinical programs, ensuring clear decision-making, issue resolution, and alignment across internal and external stakeholdersQuality, Compliance & Inspection ReadinessEnsure continuous inspection readiness across all studies, with adherence to GCP, SOPs, and global regulatory requirementsOversee the development, implementation, and continuous improvement of Clinical Operations processes, systems, and SOPs to support scalable, high-quality executionLead audit and inspection preparedness and response, ensuring timely and effective resolution of findings through robust CAPA managementCross-Functional Leadership & Stakeholder EngagementPartner closely with Clinical Development, Regulatory, Biostatistics, Data Management, Pharmacovigilance, Legal, Finance, and other key functions to ensure integrated, high-quality program executionServe as a key interface with executive leadership, providing clear, data-driven updates on program status, risks, and strategic considerationsFoster strong collaboration with external partners, including CROs, vendors, and alliance partners, ensuring alignment, accountability, and performance excellencePeople Leadership & Organizational DevelopmentBuild, lead, and develop a high-performing Clinical Operations organization, including recruitment, coaching, performance management, and succession planningEstablish a culture of accountability, operational excellence, and continuous improvement, empowering teams to deliver high-quality results across multiple concurrent programsDrive organizational capability building, including adoption of best practices, tools, and training to support evolving clinical development needsOperational Excellence & InnovationLead continuous improvement initiatives to enhance efficiency, quality, and scalability of clinical operationsLeverage data, metrics, and analytics to inform decision-making, monitor performance, and drive proactive interventionsAdvance the adoption of innovative technologies and digital solutions to modernize trial execution and improve patient and site experienceEducation/Experience/SkillsBachelor’s degree rmacy or Life Sciences from accredited college or university, or equivalent experience; M.B.A. or advanced degree preferredMinimum 10 years of experience in pharmaceutical industry with at least 5 years of hands-on managerial experience running clinical trials and managing teamsExperience in the conduct of hospital or clinic-based clinical research trials; rare disease experience preferredDemonstrated experience leading Clinical Operations to deliver on-time, on-budget high quality outcomes supporting the Clinical Development portfolioExcellent written and oral English communication and presentation skills with excellent professional demeanor and presenceDemonstrated, 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 preferredStrong MS Office SkillsExcellent analytical and organizational skills; able to set priorities and meet deadlinesAbility to work effectively on a team in an entrepreneurial environment with proven ability to forge cross-functional working relationships with internal teamsStrong project planning, leadership and negotiation skills and the ability to contribute creative yet practical solutions/resolutions to problemsSelf-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environmentAttention to detail and good documentation practicesAbility to travel up to 20% with short notice when necessaryCatalyst 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: https://www.linkedin.com/company/catalystforrare/life/life-at-catalyst/?viewAsMember=true
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