H-1B Visa Clinical Operations Lead Jobs
Clinical Operations Lead roles qualify as H-1B visa specialty occupations under USCIS guidelines, requiring at least a bachelor's degree in clinical research, life sciences, or a related field. Sponsors file an LCA with DOL before your I-129 petition, certifying your role meets prevailing wage standards for your work location.
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DESCRIPTION
Smart Delivery Technologies (SDT) is building the sensing, edge intelligence, and interfaces that make Amazon's delivery network the world's safest and most efficient logistics operation — from the delivery station to the customer's doorstep. Our portfolio includes real-time hazard detection, guidance systems for drivers and associates, environmental data capture, and edge compute devices.
We are looking for a Senior New Product Introduction (NPI) Technical Program Manager (TPM), Operations to lead new products end-to-end at the intersection of engineering, supply chain, and operations. This role requires someone who can drive cross-functional execution while also going deep on build and sourcing strategy, supplier negotiations, and cost structure.
The ideal candidate has a strong background in Operations Program Management (OPM), is comfortable owning supplier sourcing decisions, and can build and defend detailed costing breakdowns (BOM cost, tooling, NRE, landed cost) that inform business decisions. You will partner with engineering, product, finance, procurement, and manufacturing teams to launch new products on time, at target cost, and at the right quality bar.
Because SDT lives inside an operations org, our timelines are tight and we must justify product value through pilots before progressing toward mass production. The right person embraces this tension: applying the rigor of a high-volume NPI process while pragmatically right-sizing it to an operations-driven, pilot-to-production reality. This is a high-visibility role for someone who thrives in ambiguity, dives deep into data, and is equally comfortable in a supplier negotiation, a design review, or a business review with senior leadership. Travel should be expected up to 25-30% of the time to engage with suppliers and contract manufacturers globally for builds and relationship development.
Key job responsibilities
- Own the end-to-end NPI program plan across multiple concurrent product launches, from design freeze through mass production ramp
- Drive OPM rigor: schedules, milestones, risk registers, and readiness reviews across engineering, supply chain, quality, and manufacturing
- Lead supplier sourcing strategy, including RFQs, supplier selection, and negotiations in partnership with procurement
- Own material availability across multiple programs by partnering with key component suppliers, manufacturing partners, and product owners to proactively drive sourcing activities and risk buy authorizations
- Build and maintain detailed costing breakdowns (component-level BOM cost, tooling/NRE, labor, overhead, landed cost) and identify cost-reduction opportunities
- Monitor and proactively manage component and product-level End of Life (EOL)
- Partner with finance to align program costs against business case targets and flag variances early
- Identify, track, and resolve program risks and blockers; escalate trade-offs to leadership with clear data-backed recommendations
- Drive design-for-cost and design-for-manufacturability discussions with engineering teams
- Plan and execute pilots/POCs that justify product value, and translate pilot results into go/no-go decisions and the path toward mass production
- Create and present program status, cost, and sourcing updates to senior leadership on a regular cadence
- Establish and improve NPI processes, tools, and mechanisms to scale program management across the organization
BASIC QUALIFICATIONS
- 6+ years of project management disciplines including scope, schedule, budget, quality, along with risk and critical path management experience
- Bachelor's degree in engineering, computer science or equivalent
- 6+ years of technical program management experience
- 4+ years of relevant strategic sourcing including vendor negotiations, global contract management, process improvement, operational and financial analysis experience
- Experience in written and verbal communication with the ability to present complex technical information in a clear and concise manner to executives and non-technical leaders
- Experience managing global supply chains and contract manufacturer (CM/ODM) relationships
- Hands-on experience building and analyzing costing breakdowns (BOM cost, tooling/NRE, landed cost)
- Experience managing cross-functional programs involving engineering, supply chain, and manufacturing, shipping multiple products from concept to mass production
PREFERRED QUALIFICATIONS
- Project Management Professional (PMP) or equivalent certification
- Experience working across teams and influencing teams that are not your own
- Experience in consumer hardware, electronics, or high-volume manufacturing environments
- Experience with cost modeling tools and should-cost analysis
- Experience deploying hardware into operations, logistics, or safety-critical environments
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.
The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at https://amazon.jobs/en/benefits.
LOCATION
USA, WA, BELLEVUE - 148,700.00 - 201,200.00 USD annually
See all 4,046+ H-1B Visa Clinical Operations Lead Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Clinical Operations Lead
Verify your degree supports specialty occupation
USCIS requires a direct relationship between your degree field and Clinical Operations Lead duties. A degree in clinical research, nursing, public health, or life sciences strengthens your case far more than a general business degree.
Check employer LCA filings by occupation
Use Migrate Mate to filter employers by verified DOL Labor Condition Application filings for clinical operations roles, so you're targeting companies with documented H-1B sponsorship history rather than guessing from job postings alone.
Target CROs and sponsor-heavy pharma companies
Contract Research Organizations and large pharmaceutical companies file H-1B petitions for clinical operations roles consistently. Prioritize employers with active clinical trial pipelines, since role demand directly drives their willingness to sponsor.
Benchmark your prevailing wage before negotiating
Use the OFLC Wage Search to look up the prevailing wage for your SOC code and work location before accepting an offer. Your employer's LCA must certify they'll pay at least that amount, so knowing it protects your negotiating position.
Confirm your role's scope covers supervisory duties
USCIS scrutinizes Clinical Operations Lead petitions where the job description blurs with coordinator-level work. Ensure your offer letter explicitly frames your responsibilities around oversight, protocol development, and cross-functional team leadership.
Submit your petition before the April cap deadline
H-1B cap registrations open in March for October 1 start dates. Clinical operations roles at cap-subject employers require selection in the lottery, so you and your employer need to align on timing well before the USCIS registration window closes.
H-1B Visa Clinical Operations Lead: Frequently Asked Questions
Does a Clinical Operations Lead role qualify as an H-1B specialty occupation?
Yes, provided the employer requires at least a bachelor's degree in a directly related field such as clinical research, life sciences, nursing, or public health. USCIS evaluates whether the degree requirement is specific to the role, not just any bachelor's degree. Roles that accept unrelated degrees or substitute years of experience without a degree requirement face higher petition scrutiny.
Which employers sponsor H-1B visas for Clinical Operations Lead positions?
Large pharmaceutical companies, biotechnology firms, and Contract Research Organizations are the most consistent H-1B sponsors for clinical operations roles. Academic medical centers and hospital networks also sponsor for clinical trial oversight positions. You can browse verified sponsoring employers on Migrate Mate, which surfaces companies with confirmed DOL LCA filing history for this role type.
How does the H-1B prevailing wage requirement apply to this role?
Before filing your I-129 petition, your employer must file an LCA with DOL certifying they'll pay you at least the prevailing wage for a Clinical Operations Lead in your specific work location. Wage levels vary by geography and experience tier. You can verify the applicable wage using the OFLC Wage Search tool, which reports wages by SOC code and metropolitan area.
Can I transfer my H-1B to a new employer if I switch clinical operations jobs?
Yes, H-1B portability lets you 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 is valid and you haven't violated status. Your new employer must file a new LCA and I-129 covering the Clinical Operations Lead role at the new company before your start date.
What happens to my H-1B status if my clinical trial project ends or my role is eliminated?
If your employer terminates your position, you enter a 60-day grace period during which you can seek a new sponsoring employer, change to another visa status, or depart the U.S. Your previous employer is responsible for your return transportation costs if they terminate you before your authorized period ends. Acting quickly on a transfer petition within that window preserves your options.