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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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 H-1B Visa Clinical Operations Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Clinical Operations Lead Jobs.
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.