Clinical Operations Lead Green Card Jobs
Clinical Operations Lead roles at U.S. clinical research organizations, biotech firms, and hospital networks regularly qualify for EB-2 and EB-3 green card sponsorship through PERM labor certification. Employers file on your behalf, certifying the role requires a specialized degree and that no qualified U.S. worker is available for the position.
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Get Access To All JobsThe Role:
As we expand our late-stage development organization, we are seeking a Director, Clinical Operations– COPD to provide strategic and operational leadership for global Phase 3 development. This role will serve as the operational leader across one or more complex, late-stage COPD studies, with full accountability for study strategy, execution, quality, budget, and delivery.
In addition to program leadership, this role includes direct line management of Clinical Operations professionals, with responsibility for hiring, developing, coaching, and building high-performing teams. The Director will play a key role in shaping operational strategy, advancing functional excellence, and strengthening Generate’s late-stage development capabilities.
Here's how you will contribute:
Program Leadership
- Provide strategic oversight and end-to-end operational leadership for global Phase 3 COPD studies and related development activities.
- Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives.
- Accountable for study timelines, budgets, resource allocation, quality metrics, and overall delivery.
- Lead scenario planning, risk forecasting, and mitigation strategies at the program level.
- Partner with Clinical Development leadership to inform portfolio-level planning and decision-making.
People Leadership & Organizational Development
- Directly manage and develop Clinical Operations staff (e.g., Clinical Trial Leads and/or Clinical Trial Managers).
- Recruit, hire, onboard, and retain top talent to support late-stage clinical development.
- Set performance expectations, conduct evaluations, provide coaching, and support career development.
- Build a culture of accountability, collaboration, and operational excellence.
Cross-Functional Collaboration
- Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC.
- Act as a primary point of accountability across internal stakeholders, CRO partners, and external vendors.
- Enable effective decision-making, timely escalation, and transparent communication across teams.
Operational Excellence & Risk Management
- Oversee global study startup, site strategy, enrollment execution, monitoring approaches, and patient engagement initiatives.
- Ensure compliance with ICH-GCP, global regulatory requirements, and internal SOPs.
- Provide oversight of study budgets, vendor performance, and quality metrics.
- Establish performance metrics and drive continuous improvement across external partnerships.
- Lead inspection readiness strategy and support regulatory inspections.
- Drive proactive issue identification, risk management, and CAPA oversight.
Functional Leadership & Process Improvement
- Contribute to Clinical Operations strategy, infrastructure development, and process optimization.
- Champion innovation in trial execution, including digital tools, decentralized approaches, and patient-focused strategies.
- Share best practices and help define standards across the clinical operations organization.
The Ideal Candidate will have:
- 12–15+ years of clinical operations experience within the pharmaceutical or biotechnology industry.
- Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) is strongly preferred.
- Significant experience leading global late-phase (Phase 3) studies.
- Demonstrated success in direct people management, including hiring, performance management, and team development.
- Proven ability to lead complex cross-functional teams and influence at senior leadership levels.
- Strong expertise in CRO oversight, global regulatory environments, and inspection readiness.
- Strategic thinker with strong operational execution skills.
- Deep working knowledge of ICH/GCP and global clinical development regulations.
Nice to Have
- Late-phase respiratory or immunology therapeutic area experience.
- Experience building or scaling clinical development functions in a high-growth organization.
Who Will Love This Job:
Generate:Biomedicines is pioneering Generative Biology™ to design and develop novel therapeutics with unprecedented precision. As a Director, you will play a critical role not only in delivering a high-impact late-stage asthma program but also in shaping how we build and scale our clinical development organization.
You’ll join a collaborative, curious, patient-first team where scientific creativity and operational excellence come together to advance programs with the potential for large-scale impact.
About Generate Biomedicines
We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.
Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.
At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital
The Role:
As we expand our late-stage development organization, we are seeking a Director, Clinical Operations– COPD to provide strategic and operational leadership for global Phase 3 development. This role will serve as the operational leader across one or more complex, late-stage COPD studies, with full accountability for study strategy, execution, quality, budget, and delivery.
In addition to program leadership, this role includes direct line management of Clinical Operations professionals, with responsibility for hiring, developing, coaching, and building high-performing teams. The Director will play a key role in shaping operational strategy, advancing functional excellence, and strengthening Generate’s late-stage development capabilities.
Here's how you will contribute:
Program Leadership
- Provide strategic oversight and end-to-end operational leadership for global Phase 3 COPD studies and related development activities.
- Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives.
- Accountable for study timelines, budgets, resource allocation, quality metrics, and overall delivery.
- Lead scenario planning, risk forecasting, and mitigation strategies at the program level.
- Partner with Clinical Development leadership to inform portfolio-level planning and decision-making.
People Leadership & Organizational Development
- Directly manage and develop Clinical Operations staff (e.g., Clinical Trial Leads and/or Clinical Trial Managers).
- Recruit, hire, onboard, and retain top talent to support late-stage clinical development.
- Set performance expectations, conduct evaluations, provide coaching, and support career development.
- Build a culture of accountability, collaboration, and operational excellence.
Cross-Functional Collaboration
- Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC.
- Act as a primary point of accountability across internal stakeholders, CRO partners, and external vendors.
- Enable effective decision-making, timely escalation, and transparent communication across teams.
Operational Excellence & Risk Management
- Oversee global study startup, site strategy, enrollment execution, monitoring approaches, and patient engagement initiatives.
- Ensure compliance with ICH-GCP, global regulatory requirements, and internal SOPs.
- Provide oversight of study budgets, vendor performance, and quality metrics.
- Establish performance metrics and drive continuous improvement across external partnerships.
- Lead inspection readiness strategy and support regulatory inspections.
- Drive proactive issue identification, risk management, and CAPA oversight.
Functional Leadership & Process Improvement
- Contribute to Clinical Operations strategy, infrastructure development, and process optimization.
- Champion innovation in trial execution, including digital tools, decentralized approaches, and patient-focused strategies.
- Share best practices and help define standards across the clinical operations organization.
The Ideal Candidate will have:
- 12–15+ years of clinical operations experience within the pharmaceutical or biotechnology industry.
- Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) is strongly preferred.
- Significant experience leading global late-phase (Phase 3) studies.
- Demonstrated success in direct people management, including hiring, performance management, and team development.
- Proven ability to lead complex cross-functional teams and influence at senior leadership levels.
- Strong expertise in CRO oversight, global regulatory environments, and inspection readiness.
- Strategic thinker with strong operational execution skills.
- Deep working knowledge of ICH/GCP and global clinical development regulations.
Nice to Have
- Late-phase respiratory or immunology therapeutic area experience.
- Experience building or scaling clinical development functions in a high-growth organization.
Who Will Love This Job:
Generate:Biomedicines is pioneering Generative Biology™ to design and develop novel therapeutics with unprecedented precision. As a Director, you will play a critical role not only in delivering a high-impact late-stage asthma program but also in shaping how we build and scale our clinical development organization.
You’ll join a collaborative, curious, patient-first team where scientific creativity and operational excellence come together to advance programs with the potential for large-scale impact.
About Generate Biomedicines
We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.
Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.
At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital
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Get Access To All JobsTips for Finding Green Card Sponsorship in Clinical Operations Lead
Document your CRA and CRC credentials early
PERM requires your employer to verify your qualifications meet the job's minimum requirements. Gather transcripts, clinical research certifications like ACRP or SOCRA credentials, and employment records before your employer begins the labor certification filing.
Target employers with active PERM filing history
Not all CROs or biotech firms sponsor green cards regularly. Search OFLC PERM disclosure data to identify which organizations have certified Clinical Operations roles before, then prioritize those companies in your job search.
Clarify EB-2 versus EB-3 fit with your hiring manager
If the posted role requires a master's degree in a clinical or life sciences field, ask whether the employer will file under EB-2. That classification can meaningfully shorten your green card timeline depending on your country of birth.
Use Migrate Mate to find green card sponsoring roles
Filtering job boards manually for sponsorship willingness wastes time. Migrate Mate surfaces Clinical Operations Lead openings specifically at employers with PERM and I-140 sponsorship history, so you apply where the pathway already exists.
Negotiate the PERM job description before signing your offer
The labor certification locks in the role's minimum requirements. If your offer letter describes duties too narrowly or lists overly specific software requirements, ask HR to align the PERM job description with standard SOC occupational language before filing begins.
Understand how DOL audit risk affects your filing timeline
PERM applications for managerial clinical roles face higher DOL audit rates because of their hybrid oversight responsibilities. Ask your employer's immigration counsel whether they'll use a supervised or assisted recruitment approach to reduce audit exposure and processing delays.
Clinical Operations Lead jobs are hiring across the US. Find yours.
Find Clinical Operations Lead JobsClinical Operations Lead Green Card Sponsorship: Frequently Asked Questions
Does a Clinical Operations Lead role qualify for EB-2 or EB-3 green card sponsorship?
Most Clinical Operations Lead positions qualify for EB-3 as skilled professional roles requiring at least a bachelor's degree in a clinical, biological, or health sciences field. If your employer structures the role to require a master's degree or you hold an advanced degree central to the duties, EB-2 may apply. Your employer's immigration counsel determines the category based on the actual job requirements, not your personal credentials alone.
How does PERM green card sponsorship differ from H-1B sponsorship for this role?
H-1B is a temporary status with a three-year initial period, annual cap exposure, and lottery risk. PERM-based green card sponsorship is a permanent residency pathway with no annual cap at the EB-3 level for most countries other than India and China. The trade-off is timeline: PERM labor certification, I-140 approval, and adjustment of status typically take two to four years for most nationalities, but the outcome is lawful permanent residency rather than another renewal cycle.
What does the PERM labor certification process actually require from my employer?
Your employer must conduct a supervised recruitment campaign documenting that no qualified U.S. worker is available for the role at the prevailing wage. DOL sets the prevailing wage based on your job title, duties, and work location using OFLC Wage Search data. For Clinical Operations Lead roles, employers typically run advertisements, post with state workforce agencies, and compile rejection logs before filing the ETA Form 9089 with DOL.
How do I find Clinical Operations Lead jobs where the employer will sponsor a green card?
Most job postings don't specify PERM sponsorship willingness. Migrate Mate filters roles specifically by employers with verified green card sponsorship history, including PERM filings for clinical operations titles. Searching that way means you're applying to companies that have already navigated the process, not hoping a recruiter will bring it up after the offer stage.
Can I switch employers after my I-140 is approved without losing my green card progress?
Yes, under AC21 portability rules, you can change employers after your I-140 has been approved and your adjustment of status application has been pending for at least 180 days, provided the new role is in the same or a similar occupational classification. Clinical operations management roles typically qualify as same or similar to each other. USCIS evaluates portability claims on the SOC code and duties, so document the overlap carefully before making a move.
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