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 JobsWhy Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and lead a team to drive the strategy and implementation of feasibility and study start-up across all clinical programs.
The Opportunity to Make a Difference
We are seeking an associate director-level candidate with clinical operations experience, with specific expertise in feasibility and study start-up, who is interested in applying their experience to develop, build out, and implement innovative feasibility and study start-up activities within Sarepta that positively impact our clinical programs.
The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and will lead a team to drive the strategy and implementation of country and site feasibility for our studies and support the internalization of country and site feasibility. The candidate will drive study start-up activities and be responsible for oversight of timelines and goals with respect to our clinical studies. The candidate will be responsible for directing and overseeing the success of Sarepta’s clinical trial feasibility process, leading the development of feasibility and start-up strategies, including study-specific plans, and directing and overseeing the success of Sarepta’s clinical trial start-up activities.
This is a highly cross-functional position, requiring collaboration with internal teams, CROs, and vendors. The candidate must be comfortable working directly with clinical trial sites.
The contribution of the candidate directly supports the goals of the Development Operations organization under R&D.
This is a great opportunity for an individual with an operational background and innovative mindset to help us accelerate study execution to support Sarepta’s goal of Patient’s First.
More about You
Primary Responsibilities Include:
- Develop and implement feasibility and start-up strategies to support the success of Sarepta’s clinical studies.
- Oversee study feasibility activities, including country, site, and investigator selection for participation in Sarepta clinical studies.
- Gather cross-functional, country-level input to inform robust feasibility strategies.
- Develop and manage integrated feasibility and site start-up timelines, and report on progress, including plans to address potential timing risks or gaps.
- Establish study-specific meetings to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO; report metrics to broader teams, including senior management.
- Lead calls with Sarepta and CRO partners to manage feasibility and study start-up activities and ensure study timelines are achieved.
- Foster a culture of innovation by developing new ideas and programs to advance feasibility and support departmental growth.
- Provide guidance and mentorship to junior members of the Study Start-up and Feasibility team.
- Create reporting tools to measure ongoing activities, as well as key performance, quality, and effectiveness indicators.
- Partner with Clinical Operations, CRO teams, and other key stakeholders to implement innovative feasibility initiatives, including data collection within CTMS.
- Support and/or lead the development of charters and SOPs related to Study Start-up and Feasibility.
- May have direct reports.
Desired Education and Skills:
- BA/BS degree in a related field; 10+ years related experience in the pharmaceutical or biotech industry within a clinical operations or project management role or similar
- Experience in clinical study budget planning, and program implementation
- Experience with both direct line management and dotted line reporting
- Experience in developing feasibility questionnaires
- Experience with protocol and ICF development and review
- Experience in clinical study start-up
- Experience with rare disease / difficult to recruit populations a plus
- Experience identifying and managing multiple CROs, vendors, budgets, KPIs
- Comprehensive regulatory knowledge, including ICH and GCPs
- Exceptional organizational skills and ability to deal with competing priorities
- Strong analytical reasoning and problem-solving ability
- Excellent PowerPoint slide development and presentation skills
- Ability to multi-task, work independently and as part of a multidisciplinary team, exercise sound judgement and escalate issues when necessary
What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
LI-Hybrid
This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $160,800 - $201,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and lead a team to drive the strategy and implementation of feasibility and study start-up across all clinical programs.
The Opportunity to Make a Difference
We are seeking an associate director-level candidate with clinical operations experience, with specific expertise in feasibility and study start-up, who is interested in applying their experience to develop, build out, and implement innovative feasibility and study start-up activities within Sarepta that positively impact our clinical programs.
The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and will lead a team to drive the strategy and implementation of country and site feasibility for our studies and support the internalization of country and site feasibility. The candidate will drive study start-up activities and be responsible for oversight of timelines and goals with respect to our clinical studies. The candidate will be responsible for directing and overseeing the success of Sarepta’s clinical trial feasibility process, leading the development of feasibility and start-up strategies, including study-specific plans, and directing and overseeing the success of Sarepta’s clinical trial start-up activities.
This is a highly cross-functional position, requiring collaboration with internal teams, CROs, and vendors. The candidate must be comfortable working directly with clinical trial sites.
The contribution of the candidate directly supports the goals of the Development Operations organization under R&D.
This is a great opportunity for an individual with an operational background and innovative mindset to help us accelerate study execution to support Sarepta’s goal of Patient’s First.
More about You
Primary Responsibilities Include:
- Develop and implement feasibility and start-up strategies to support the success of Sarepta’s clinical studies.
- Oversee study feasibility activities, including country, site, and investigator selection for participation in Sarepta clinical studies.
- Gather cross-functional, country-level input to inform robust feasibility strategies.
- Develop and manage integrated feasibility and site start-up timelines, and report on progress, including plans to address potential timing risks or gaps.
- Establish study-specific meetings to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO; report metrics to broader teams, including senior management.
- Lead calls with Sarepta and CRO partners to manage feasibility and study start-up activities and ensure study timelines are achieved.
- Foster a culture of innovation by developing new ideas and programs to advance feasibility and support departmental growth.
- Provide guidance and mentorship to junior members of the Study Start-up and Feasibility team.
- Create reporting tools to measure ongoing activities, as well as key performance, quality, and effectiveness indicators.
- Partner with Clinical Operations, CRO teams, and other key stakeholders to implement innovative feasibility initiatives, including data collection within CTMS.
- Support and/or lead the development of charters and SOPs related to Study Start-up and Feasibility.
- May have direct reports.
Desired Education and Skills:
- BA/BS degree in a related field; 10+ years related experience in the pharmaceutical or biotech industry within a clinical operations or project management role or similar
- Experience in clinical study budget planning, and program implementation
- Experience with both direct line management and dotted line reporting
- Experience in developing feasibility questionnaires
- Experience with protocol and ICF development and review
- Experience in clinical study start-up
- Experience with rare disease / difficult to recruit populations a plus
- Experience identifying and managing multiple CROs, vendors, budgets, KPIs
- Comprehensive regulatory knowledge, including ICH and GCPs
- Exceptional organizational skills and ability to deal with competing priorities
- Strong analytical reasoning and problem-solving ability
- Excellent PowerPoint slide development and presentation skills
- Ability to multi-task, work independently and as part of a multidisciplinary team, exercise sound judgement and escalate issues when necessary
What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
LI-Hybrid
This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $160,800 - $201,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
See all Clinical Operations Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Clinical Operations Lead roles.
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.
Frequently 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 visa 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.