H-1B Visa Clinical Research Director Jobs
Clinical Research Director roles qualify as H-1B visa specialty occupations under USCIS guidelines, requiring at least a bachelor's degree in a directly related field. Pharma, biotech, and CRO employers file H-1B visa petitions for this title regularly. The 85,000-slot annual cap and lottery apply, so timing your job search around the April registration window matters.
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Get Access To All JobsJob title: Clinical Research Director - Immunology and Inflammation
Location: Cambridge, MA / Morristown, NJ
About the job
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
The Clinical Research Director (CRD), Immunology and Inflammation Therapeutic Area, Solid Organ Transplant focus, is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy. In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees.
The role requires a self-starting, creative, well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks. They must be able to comfortably operate independently and within a matrix team, both face to face and remotely.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities:
Some of the CRD’s core job responsibilities include those listed below, as well as all other duties assigned.
Scientific and technical expertise
- Has and maintains deep scientific, technical and clinical expertise in transplant, nephrology, hepatology and/or immunology/inflammation field
- Has a demonstrated track record in clinical development, with Phase 3 experience being an advantage
- Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on antibody is a plus
- Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
- Maintains visibility within the dermatology field to maintain credibility with internal and external stakeholders
Clinical research planning and execution
- Contributes to the development of the clinical strategy and plan
- Leads the development of the Abbreviated Protocol and Protocol development
- Represents the clinical function on Clinical Study Teams and other teams as appropriate
- Provides input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge about the pathway and effects of the drug
- Ensure that all development activities are targeted towards timely achievement (e.g. Abbreviated Protocol and protocol before study start, committees management and centralized monitoring during study, and KRM & CSR preparation at study end)
- Interacts with opinion leaders and external consultants
- Serve as medical monitor for the studies assigned
Regulatory responsibilities
- Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
- Ensures clinical data meets all necessary regulatory standards
- Supports registrations, label submissions and modifications (contributes to IB, DSUR, Briefing Package for Health Authorities)
- Participates in Advisory Committee preparation
Scientific data dissemination
- Ensures timely submission and dissemination of clinical data
- Supports the planning of advisory board meetings
- Establishes and maintains appropriate collaborations with knowledge experts
In addition to the above activities the CRD must ensure that all activities of the Global Project Team (GPT) are conducted in compliance with current regulations, laws and guidance from FDA, EMEA, and CHMP, as well as with Sanofi’s policies and procedures.
About You
Basic Qualifications:
- Medical Doctor with transplant, nephrology, hepatology or immunology clinical expertise preferred
- Minimum 2 years experience in pharmaceutical drug development and/or clinical research
- Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus
- Strong scientific and academic background with deep understanding of the disease
- Clinical research or pharmaceutical experience medicine experience in transplant/immunology field
- Knowledge of drug development and in immunology
- Good networking ability in cross-cultural environment
- Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
- Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
- Fluent in English (verbal and written communication)
Why Choose Us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job title: Clinical Research Director - Immunology and Inflammation
Location: Cambridge, MA / Morristown, NJ
About the job
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
The Clinical Research Director (CRD), Immunology and Inflammation Therapeutic Area, Solid Organ Transplant focus, is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy. In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees.
The role requires a self-starting, creative, well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks. They must be able to comfortably operate independently and within a matrix team, both face to face and remotely.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities:
Some of the CRD’s core job responsibilities include those listed below, as well as all other duties assigned.
Scientific and technical expertise
- Has and maintains deep scientific, technical and clinical expertise in transplant, nephrology, hepatology and/or immunology/inflammation field
- Has a demonstrated track record in clinical development, with Phase 3 experience being an advantage
- Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on antibody is a plus
- Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
- Maintains visibility within the dermatology field to maintain credibility with internal and external stakeholders
Clinical research planning and execution
- Contributes to the development of the clinical strategy and plan
- Leads the development of the Abbreviated Protocol and Protocol development
- Represents the clinical function on Clinical Study Teams and other teams as appropriate
- Provides input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge about the pathway and effects of the drug
- Ensure that all development activities are targeted towards timely achievement (e.g. Abbreviated Protocol and protocol before study start, committees management and centralized monitoring during study, and KRM & CSR preparation at study end)
- Interacts with opinion leaders and external consultants
- Serve as medical monitor for the studies assigned
Regulatory responsibilities
- Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
- Ensures clinical data meets all necessary regulatory standards
- Supports registrations, label submissions and modifications (contributes to IB, DSUR, Briefing Package for Health Authorities)
- Participates in Advisory Committee preparation
Scientific data dissemination
- Ensures timely submission and dissemination of clinical data
- Supports the planning of advisory board meetings
- Establishes and maintains appropriate collaborations with knowledge experts
In addition to the above activities the CRD must ensure that all activities of the Global Project Team (GPT) are conducted in compliance with current regulations, laws and guidance from FDA, EMEA, and CHMP, as well as with Sanofi’s policies and procedures.
About You
Basic Qualifications:
- Medical Doctor with transplant, nephrology, hepatology or immunology clinical expertise preferred
- Minimum 2 years experience in pharmaceutical drug development and/or clinical research
- Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus
- Strong scientific and academic background with deep understanding of the disease
- Clinical research or pharmaceutical experience medicine experience in transplant/immunology field
- Knowledge of drug development and in immunology
- Good networking ability in cross-cultural environment
- Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
- Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
- Fluent in English (verbal and written communication)
Why Choose Us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
See all 340+ H-1B Visa Clinical Research Director Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Clinical Research Director Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Clinical Research Director
Verify your degree meets specialty occupation standards
USCIS requires your degree field to directly relate to clinical research oversight. A general business or unrelated science degree without supplemental coursework or advanced credentials can trigger an RFE. Document how your academic training connects specifically to trial management and regulatory oversight.
Target employers with active IND portfolios
Companies managing Investigational New Drug applications with the FDA run ongoing Phase II and III trials, making H-1B sponsorship a recurring business need rather than a one-off request. Pharma and mid-size CROs with active pipelines file more consistently than academic medical centers.
Search H-1B sponsoring employers on Migrate Mate
Use Migrate Mate to filter Clinical Research Director roles by employers with verified H-1B LCA filing history. This surfaces companies that have already cleared DOL prevailing wage certification for this occupation code, not just those who claim they sponsor.
Confirm the prevailing wage tier before negotiating
Run the OFLC Wage Search for SOC code 11-9121 in your target metro before accepting an offer. Your employer's LCA must certify wages at the DOL prevailing wage level for that location. A mismatch between offered salary and certified wage level can stall or invalidate the petition.
Account for the H-1B cap-subject lottery timeline
Cap-subject petitions must be filed by April 1 for an October 1 start date. If you're transitioning from OPT or another status, align your job search to secure an offer by February so your employer has time to prepare the LCA and I-129 before the registration window opens.
Ask whether the employer uses premium processing
USCIS premium processing upgrades I-129 adjudication to a 15-business-day window. For senior director roles with delayed start dates or pending credentialing requirements, confirm upfront whether your prospective employer will elect premium processing, since standard processing can run several months.
H-1B Visa Clinical Research Director: Frequently Asked Questions
Does a Clinical Research Director role qualify as an H-1B specialty occupation?
Yes. USCIS classifies Clinical Research Director as a specialty occupation because the role typically requires at least a bachelor's degree in a specific field such as life sciences, clinical pharmacology, or biomedical research. Employers document this requirement in the H-1B petition. Roles where any unrelated bachelor's degree satisfies the position do not qualify, so your offer letter and job description should specify the required degree field.
Which types of employers sponsor H-1B visas for Clinical Research Director positions?
Pharmaceutical companies, contract research organizations, biotechs with active IND pipelines, and large academic medical centers with industry-funded trials are the most consistent sponsors. Smaller sponsors occasionally include medical device firms and specialty CROs. Migrate Mate filters these employers by verified LCA filing history for this occupation, so you can focus on companies that have completed DOL wage certification for this role before you apply.
How does the DOL prevailing wage requirement affect Clinical Research Director offers?
Before filing the H-1B petition, your employer must obtain a certified Labor Condition Application from the DOL confirming the offered wage meets the prevailing wage for your job location. You can check the applicable wage level using the OFLC Wage Search with SOC code 11-9121 and your target metro. If the initial offer falls below the certified level, the employer must adjust it before the LCA is approved.
Can I transfer my H-1B to a new Clinical Research Director role during employment?
Yes. Under H-1B portability rules, you can start working for a new employer once they file a cap-exempt transfer petition with USCIS, without waiting for approval, as long as you've been in valid H-1B status. The new employer files a fresh I-129 and LCA for the new position. The specialty occupation and prevailing wage requirements apply to each new petition independently.
What credentials strengthen an H-1B petition for a Clinical Research Director?
A graduate degree in a clinical or life sciences field, board certification in clinical research such as ACRP or SOCRA credentials, and documented leadership over multi-site trials all support the specialty occupation argument in an H-1B petition. USCIS adjudicators look for evidence that the role genuinely requires a specific body of specialized knowledge. Directors with a mix of relevant education and regulatory experience tend to face fewer Requests for Evidence than those whose degree field is only tangentially related to the position.