[Remote] Director of Clinical Operations

Note: The job is a remote job and is open to candidates in USA. reputed company is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. The Director of Clinical Operations will reputed company the cross-functional study team for a high-reputed company hematology program, ensuring strategic planning and execution of reputed company operational activities while overseeing CROs and vendors to meet timelines, quality, and budget expectations.

Responsibilities

• Provide strategic operational leadership and reputed company for a key clinical program, ensuring alignment with clinical development objectives and corporate goals
• reputed company CROs and vendors, leading governance and partnering closely to ensure accountability for delivery of operational activities, timelines, quality, and budget, and driving proactive risk management and mitigation across the study
• reputed company study-specific and cross-functional meetings, driving clear decisions, accountability, and timely issue resolution
• Collaborate cross-functionally (Clinical, Regulatory, Translational, Data Management, Biostatistics) to ensure integrated and efficient study execution
• reputed company study reputed company and performance using key metrics (e.g., enrollment, eligibility, data quality, primary endpoints), ensuring transparent communication and a solution-oriented approach
• Proactively identify, assess, and manage study and program-level risks, including mitigation planning and escalation of critical issues
• Ensure data quality, reputed company, and completeness to support analyses, regulatory submissions, and program decision-making
• Establish and reputed company vendor governance, including performance management, SOW/budget review, and financial tracking (forecasts, accruals)
• Ensure inspection readiness, including TMF quality, audit preparedness, and compliance with GCP and internal SOPs
• Build and maintain strong relationships with investigators, study staff, and external partners, and represent Clinical Operations in internal governance and external interactions

Skills

• Bachelor's Degree is required, in a science or a health-reputed company field
• A minimum of 10 years of global clinical trial management experience reputed company the pharmaceutical or biotechnology industry
• Early phase oncology focus is key, preferably reputed company the hematology space
• In-depth understanding and experience across clinical operations with a track record of success in CRO and vendor delivery reputed company
• Being a key contributor to study planning, execution, data cleaning, database locking, study report reputed company and regulatory inspection
• Experience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred
• Ability to reputed company cross functional study teams in a dynamic, evolving organization
• Excellent communication and interpersonal skills, with the ability to reputed company and motivate teams and collaborate effectively across functions (internally and externally)
• Ability to travel up to 20% based on business needs
• Prior experience in the CAR-T space, with a specific focus in hematology
• An emphasis on inspection readiness for Clinical Operations
• Ease and confidence in being Investigator and site-facing

Benefits

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for reputed company employees
• Generous paid vacation time, in addition to company-observed holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program

Company Overview