Clinical Operations Lead Jobs in USA with Visa Sponsorship
Clinical Operations Leads manage clinical trial execution and site oversight, roles that qualify as specialty occupations under H-1B visa and E-3 visas. Employers in biotech, pharma, and CROs regularly sponsor this title. A life sciences or health-related degree is typically required to support the petition. For detailed occupation requirements, see the O*NET profile.
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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 status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.
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 status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.
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Get Access To All JobsTips for Finding Clinical Operations Lead Jobs
Target CROs and biotech sponsors first
Contract research organizations and mid-size biotech companies file more Clinical Operations Lead H-1B petitions than most employers. They have established immigration infrastructure and are more experienced navigating the sponsorship process than smaller clinical sites.
Confirm your degree supports the specialty occupation
USCIS requires a direct nexus between your degree field and the role. Life sciences, nursing, public health, or biomedical engineering degrees generally satisfy this. A general business degree alone is unlikely to hold up without substantial supporting documentation.
Understand what the LCA certifies
Before your visa petition is filed, your employer submits a Labor Condition Application to the Department of Labor certifying the prevailing wage for your location and role. This step must be completed before USCIS can adjudicate your H-1B petition.
Ask about premium processing upfront
Clinical trial timelines are often fixed and delay-sensitive. Premium processing reduces USCIS adjudication to 15 business days. Raise this with your employer before accepting an offer so timelines align with your start date and any protocol obligations.
Australians should explore the E-3 pathway
The E-3 visa is available exclusively to Australian citizens and has no lottery. Clinical Operations Lead qualifies as a specialty occupation under E-3. Applications are processed at Australian consulates, and approval often comes within weeks of the interview.
Document your protocol and site management experience
Strong sponsorship cases for this role include evidence of ICH-GCP compliance work, IRB interactions, and clinical site oversight. Concrete documentation of these responsibilities strengthens the specialty occupation argument if USCIS issues a Request for Evidence.
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Find Clinical Operations Lead JobsFrequently Asked Questions
Does Clinical Operations Lead qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. USCIS evaluates whether the role normally requires a bachelor's degree or higher in a specific field. Clinical Operations Lead positions that require a life sciences, public health, or clinical research degree and involve protocol management, regulatory compliance, and site oversight generally satisfy the specialty occupation standard. Roles framed too broadly, with no specific degree requirement listed in the job posting, are more likely to receive a Request for Evidence.
What degree do I need to get sponsored as a Clinical Operations Lead?
Most successful H-1B and E-3 petitions for this role are supported by degrees in life sciences, nursing, biomedical engineering, public health, or a closely related field. A general healthcare administration degree may work with strong supporting documentation. A degree unrelated to clinical research, such as business or liberal arts, will make the specialty occupation argument significantly harder to sustain.
Which types of employers sponsor Clinical Operations Leads most often?
Contract research organizations, mid-size and large pharmaceutical companies, and biotech firms with active clinical programs are the most active sponsors for this title. Academic medical centers occasionally sponsor as well, particularly for roles managing investigator-initiated trials. You can browse verified sponsoring employers currently hiring for this role on Migrate Mate.
Can I transfer my H-1B to a new employer if I'm already a Clinical Operations Lead?
Yes. H-1B portability allows you to start working for a new employer as soon as they file a transfer petition, without waiting for USCIS approval, as long as your current H-1B was approved and you've maintained valid status. Your new employer must file a new LCA and I-129 petition covering the Clinical Operations Lead role at the new worksite location.
How does the E-3 visa compare to the H-1B for this role?
For Australian citizens, the E-3 is a significantly more predictable path. There's no annual lottery, the 10,500-slot annual allocation has never been fully used, and consular processing in Sydney, Melbourne, or Perth typically takes a few weeks. The specialty occupation and degree requirements are the same as H-1B. Both allow two-year validity periods, but E-3 renewals are processed at the consulate rather than through USCIS.
What is the prevailing wage requirement for sponsored Clinical Operations Lead jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.
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