Director, Clinical Operations
Job Description
Role Objective: Company is seeking a highly experienced Clinical Operations Director-level to provide hands-on leadership supporting completion of two clinical programs (Phase 2 pivotal study and phase 1 supportive study). This 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.
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.
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