Senior Director, Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic and operational leadership for the comprehensive execution of the clinical development portfolio.

• Define and implement Clinical Operations strategies that are in alignment with the clinical development plan.

• Oversee portfolio planning, resource distribution, capacity forecasting, and budget management.

• Assess therapeutic programs and early-stage opportunities to pinpoint operational requirements, risks, and possibilities.

• Lead the selection, contracting, governance, and performance oversight of vendors and CROs.

• Introduce advanced tools, technologies, analytics, and decentralized or hybrid trial methodologies.

• Offer executive oversight for clinical trial activities across all phases.

• Establish and sustain integrated study plans, timelines, budgets, and performance metrics.

• Propel risk-based study management and operational risk reduction.

• Supervise protocol input, study initiation, site feasibility and selection, activation, enrollment, monitoring, database lock, and closure.

• Act as the primary escalation point and executive sponsor for clinical programs.

• Ensure continuous inspection readiness and compliance with GCP, SOPs, and global regulatory mandates.

• Oversee audit and inspection preparedness, responses, and CAPA management.

• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, Legal, Finance, and other departments.

• Provide executive leadership with data-driven updates regarding program status, risks, and strategic considerations.

• Build, lead, and cultivate a high-performing Clinical Operations organization.

• Drive recruitment, coaching, performance management, succession planning, capability building, and training initiatives.

• Spearhead continuous improvement initiatives and advance process standardization.

• Utilize data, metrics, and analytics to monitor performance and drive necessary interventions.

• Enhance digital solutions to modernize trial execution and improve the experience for patients and sites.

⛳️ Requirements

• Bachelor’s degree in Health Science, Pharmacy, or Life Sciences from an accredited institution, or equivalent experience.

• An M.B.A. or advanced degree is preferred.

• A minimum of 10 years of experience in the pharmaceutical industry.

• At least 5 years of direct managerial experience overseeing clinical trials and managing teams.

• Therapeutic experience in Neurology or Rare/Orphan Disease is required.

• Experience in hospital or clinic-based clinical research trials.

• Rare disease experience is preferred.

• Proven experience in leading Clinical Operations to achieve on-time, on-budget, high-quality outcomes.

• Exceptional written and verbal communication skills in English, along with strong presentation abilities.

• Solid understanding of GCP, ICH, FDA regulations, global regulatory authority submissions, and relevant clinical development regulations.

• Familiarity with rare disease research guidelines is preferred.

• Proficient in MS Office applications.

• Strong analytical and organizational skills.

• Excellent project planning, leadership, and negotiation abilities.

• Capacity to work effectively in an entrepreneurial team environment and establish cross-functional relationships.

• Ability to prioritize, manage multiple tasks, and thrive in a fast-paced, demanding setting.

• Attention to detail and adherence to good documentation practices.

• Willingness 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