Role Objective: Company is seeking a highly experienced Clinical Operations Director-level consultant to provide hands-on leadership supporting completion of two clinical programs (Phase 2 pivotal study and phase 1 supportive study). The consultant will focus on study execution, database lock readiness, GCP compliance, TMF completeness, clinical trial completion activities, and operational readiness to support a planned Biologics License Application (BLA) submission.
This role requires a strong execution leader who has experience preparing trials for regulatory submissions and ensuring inspection readiness.
Key Responsibilities
BLA Readiness & Regulatory Submission Support
• Support operational readiness activities for planned BLA submission
• Ensure clinical operations deliverables support regulatory requirements
• Ensure TMF is submission and inspection ready
• Support clinical contribution to Module 5 readiness activities
• Ensure clinical study documentation is complete and audit ready
• Partner with Regulatory and Biometrics to ensure timelines align with submission strategy
• Ensure operational inspection readiness for potential FDA pre-approval inspection (PAI)
• Support CSR readiness activities from an operational perspective
• Ensure vendor documentation supports submission requirements
• Identify operational gaps that could delay submission and implement mitigation plans
Study Execution Leadership
• Lead operational execution of Phase 2 pivotal study toward database lock
• Support Phase I completion activities
• Drive study timelines and deliverables
• Run study execution meetings
• Identify risks and escalate appropriately
Database Lock Readiness
• Ensure readiness across:
Query resolution
Data cleaning
Vendor deliverables
Protocol deviation reconciliation
Safety reconciliation
Medical coding completion
• Partner closely with Data Management and Biostatistics
TMF Oversight
• Perform TMF completeness reviews
• Lead TMF remediation if needed
• Ensure inspection readiness standards
• Ensure essential documents are complete and compliant
GCP Compliance
• Ensure studies meet ICH-GCP requirements
• Support inspection readiness preparation
• Identify compliance gaps and implement corrective actions
Vendor Management
• Provide oversight of CRO and vendor performance
• Track deliverables and timelines
• Ensure vendor accountability
Cross-Functional Leadership
• Coordinate with:
Clinical Development
Biometrics
Data Management
Regulatory
Quality
• Provide regular updates to CMO and leadership
Study Closeout
• Support:
Study closeout planning
CSR readiness
Final reconciliation activities
Regulatory readiness
Required Candidate Profile
Experience
• 12+ years clinical operations experience
• Director or Associate Director level preferred
• Strong experience leading trials through database lock
• Experience supporting NDA/BLA or regulatory submissions preferred
• Strong GCP and inspection readiness experience
• Experience in biotech strongly preferred
• Rare disease or pediatric trial experience preferred
• CRO leadership experience acceptable
We are looking for a results- professional with Expertise in clinical trial execution, Risk mitigation experience, TMF management expertise, Data validation experience, Budget and vendor oversight
and Strong regulatory compliance knowledge (ICH/GCP)
Candidate must demonstrate: Proven ability to deliver inspection-ready clinical data, Strong leadership in matrix teams, Strong execution focus, Ability to work in fast-paced small biotech environment
Technical Experience Required
Hands-on experience with: EDC systems, eTMF platforms, Clinical vendor oversight
Ideal Candidate Background
Best fit candidates will typically come from:
Small biotech companies
CRO leadership roles
Rare disease programs
Cell or gene therapy companies
Nice to Have: Academic site trial experience
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
