Clinical Development Specialist Jobs in USA with Visa Sponsorship
Clinical Development Specialists manage clinical trial operations for pharmaceutical, biotech, and medical device companies, roles that routinely qualify for H-1B visa and O-1 visa sponsorship. Most positions require a life sciences degree, and many employers are experienced sponsors. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsAortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you’ll make an impact:
- Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians
- Ensure successful product lifecycle management for multiple complex projects, including:
- Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy
- Design, prepare and conduct first-in-man product evaluations, including case support for proper product use
- Create Clinical Investigator Brochure
- Develop clinical trial strategy
- Provide scientific rationale for product attributes and pre-clinical test results to regional clinical teams necessary to obtain site and country approvals
- Provide product expertise for new product introduction training for clinical and site personnel
- Design, develop, conduct, and assess results of post-market evaluations
- Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, design of validation protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.
- Ensure medical and scientific factors are considered during cross-functional product development project team meetings.
- Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports
- Consult with field trial managers to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.
- Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports.
- Other duties as assigned by leadership
What you'll need (Required):
- Bachelor's Degree in biology or life sciences field, 5 years experience Class II and III medical device technologies and/or clinical studies background Required
- Bachelor's Degree in engineering Preferred
- Travel up to 50% nationwide
- This position is based in Irvine, Ca full time on site.
What else we look for (Preferred):
- Proven expertise with computer skills – Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet
- Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
- Experience with pre-clinical testing protocols, hospital environments and sterile techniques
- Good communication and organizational skills
- Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
- Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
- Demonstrated problem-solving and critical thinking skills
- Thorough, conscientious and results oriented working style
- Team oriented
- Ability to work in a dynamic work environment
- Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you’ll make an impact:
- Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians
- Ensure successful product lifecycle management for multiple complex projects, including:
- Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy
- Design, prepare and conduct first-in-man product evaluations, including case support for proper product use
- Create Clinical Investigator Brochure
- Develop clinical trial strategy
- Provide scientific rationale for product attributes and pre-clinical test results to regional clinical teams necessary to obtain site and country approvals
- Provide product expertise for new product introduction training for clinical and site personnel
- Design, develop, conduct, and assess results of post-market evaluations
- Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, design of validation protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.
- Ensure medical and scientific factors are considered during cross-functional product development project team meetings.
- Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports
- Consult with field trial managers to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.
- Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports.
- Other duties as assigned by leadership
What you'll need (Required):
- Bachelor's Degree in biology or life sciences field, 5 years experience Class II and III medical device technologies and/or clinical studies background Required
- Bachelor's Degree in engineering Preferred
- Travel up to 50% nationwide
- This position is based in Irvine, Ca full time on site.
What else we look for (Preferred):
- Proven expertise with computer skills – Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet
- Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
- Experience with pre-clinical testing protocols, hospital environments and sterile techniques
- Good communication and organizational skills
- Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
- Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
- Demonstrated problem-solving and critical thinking skills
- Thorough, conscientious and results oriented working style
- Team oriented
- Ability to work in a dynamic work environment
- Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
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Get Access To All JobsTips for Finding Visa Sponsorship as a Clinical Development Specialist
Target biotech and pharma employers directly
Large pharmaceutical companies and contract research organizations file H-1B petitions regularly. Filtering for employers with a documented sponsorship history significantly improves your odds of landing an interview that leads to a visa offer.
Confirm your degree field aligns with the role
H-1B specialty occupation requires a degree in a directly related field. A background in nursing, biology, pharmacy, or clinical research is typically accepted. A general business degree alone may not satisfy USCIS requirements for this role.
Highlight clinical trial experience in your application
Employers sponsoring visas for this role want candidates who can justify the investment. Specific experience with Phase II or Phase III trials, protocol development, or GCP compliance strengthens both your application and the specialty occupation petition.
Ask about sponsorship before the final interview round
Many clinical development teams are open to sponsoring but haven't formalized a policy. Raising the question early, framed around your timeline and authorization status, helps both sides avoid late-stage surprises during the offer process.
Consider CRO roles as a pathway in
Contract research organizations hire Clinical Development Specialists at high volume and frequently sponsor H-1B visas. Joining a CRO builds trial experience fast and positions you well for direct pharma or biotech roles that sponsor at the senior level.
Document any regulatory or IND submission experience
Experience with IND applications, FDA correspondence, or clinical study reports signals senior-level value. Employers are more likely to invest in sponsorship for candidates whose specialized knowledge would be difficult to replace with a locally authorized hire.
Frequently Asked Questions
Do Clinical Development Specialist roles typically qualify for H-1B sponsorship?
Yes. Clinical Development Specialist positions generally meet the H-1B visa specialty occupation standard because they normally require at least a bachelor's degree in a specific field such as biology, pharmacy, nursing, or clinical research. USCIS has consistently recognized clinical research roles as qualifying, particularly when the job description ties specific duties to specialized academic training.
What degree do I need for a Clinical Development Specialist visa petition?
Most H-1B petitions for this role are supported by degrees in life sciences, nursing, pharmacy, biomedical sciences, or clinical research. A general science degree may work if your coursework aligns with the specific role requirements. A business or unrelated degree alone is unlikely to satisfy the specialty occupation requirement without significant supplemental qualifications.
Are there visa options besides the H-1B for this role?
Yes. If you have an extensive publication record, clinical trial leadership, or significant industry recognition, the O-1A visa for extraordinary ability is worth exploring. Australians may qualify for the E-3 visa, which follows a similar specialty occupation standard as the H-1B but has a separate annual allocation and no lottery.
How competitive is the H-1B lottery for clinical development roles?
The H-1B lottery applies to all cap-subject petitions regardless of job title. However, clinical development positions at hospitals, nonprofit research institutions, or universities may qualify for the cap exemption, bypassing the lottery entirely. It's worth verifying an employer's cap-exempt status before the registration window opens each March.
Where can I find Clinical Development Specialist jobs that offer visa sponsorship?
Migrate Mate is built specifically for international job seekers and filters for employers willing to sponsor. Browsing Clinical Development Specialist listings on Migrate Mate lets you focus on roles where sponsorship is part of the hiring process rather than an afterthought, which saves significant time during your job search.
What is the prevailing wage requirement for sponsored Clinical Development Specialist 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.