Senior Director, Clinical Operations

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $290k - $318k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Catalyst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2002

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Catalyst Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies for people with rare and debilitating diseases such as Lambert-Eaton myasthenic syndrome (LEMS), epilepsy, and Duchenne muscular dystrophy (DMD). Catalyst is dedicated to advancing cutting-edge science and improving the lives of patients through its clinical research pipeline, approved products, and compassionate use programs. The company actively engages in environmental, social, and governance (ESG) responsibilities and strives for social responsibility in all its endeavors.

📋 Description

• Provide strategic and operational leadership for end-to-end execution of the clinical development portfolio • Define and execute Clinical Operations strategy aligned with the clinical development plan • Lead portfolio planning, resource allocation, capacity forecasting, and budget oversight • Evaluate therapeutic programs and early-stage opportunities to identify operational needs, risks, and opportunities • Lead vendor and CRO selection, contracting, governance, and performance oversight • Implement advanced tools, technologies, analytics, and decentralized or hybrid trial methodologies • Provide executive oversight of clinical trial activities across all phases • Establish and maintain integrated study plans, timelines, budgets, and performance metrics • Drive risk-based study management and operational risk mitigation • Oversee protocol input, study start-up, site feasibility and selection, activation, enrollment, monitoring, database lock, and close-out • Serve as primary escalation point and executive sponsor for clinical programs • Ensure continuous inspection readiness and adherence to GCP, SOPs, and global regulatory requirements • Lead audit and inspection preparedness, response, and CAPA management • Partner with Clinical Development, Regulatory, Biostatistics, Data Management, Pharmacovigilance, Legal, Finance, and other functions • Provide executive leadership with data-driven updates on program status, risks, and strategic considerations • Build, lead, and develop a high-performing Clinical Operations organization • Drive recruitment, coaching, performance management, succession planning, capability building, and training • Lead continuous improvement initiatives and advance process standardization • Leverage data, metrics, and analytics to monitor performance and drive interventions • Advance digital solutions to modernize trial execution and improve patient and site experience

🎯 Requirements

• 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 • At least 5 years of hands-on managerial experience running clinical trials and managing teams • Therapeutic experience in Neurology or Rare/Orphan Disease required • Experience in 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 • Excellent written and oral English communication and presentation skills • Solid working knowledge of GCP, ICH, FDA regulations, global regulatory authority submissions, and relevant clinical development regulations • Knowledge of rare disease research guidelines preferred • Strong MS Office skills • Excellent analytical and organizational skills • Strong project planning, leadership, and negotiation skills • Ability to work effectively in an entrepreneurial team environment and forge cross-functional relationships • Ability to prioritize, multitask, and work in a fast-paced, demanding environment • Attention to detail and good documentation practices • Ability to travel up to 20% with short notice when necessary

🏖️ Benefits

• Health insurance • Dental insurance • Vision insurance • Generous paid time off • Retirement savings plan with Company Match • Competitive wages