H-1B Visa Senior Clinical Research Scientist Jobs
Senior Clinical Research Scientist roles qualify as H-1B visa specialty occupations under the life sciences SOC codes, requiring at least a bachelor's degree in a directly related field. Pharma, biotech, and CRO employers regularly file LCAs for these positions, making them a reliable category for H-1B sponsorship.
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Get Access To All JobsINTRODUCTION
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a Senior Clinical Research Scientist as part of the Clinical Development team based in Somerset, NJ.
ROLE OVERVIEW
The Clinical Research Scientist (CS) in Clinical Development is an important role in the company supporting the development and life cycle of drug development projects. The Clinical Research Scientist will work closely with the Clinical Trial Lead/Medical Lead and Clinical Trial Manager to design and implement clinical trial protocols and manage sites, CROs and other associated work. In addition, the CS will support their manager to ensure program consistency & alignment across studies, working closely with cross-functional teams for achieving project goals, within timelines & with high quality. This clinical scientist will support early phase drug development in hematology/oncology.
KEY RESPONSIBILITIES
- Responsible to ensure the data review and cleaning activities meet the quality standards to support database locks in collaboration with data management and medical lead/clinical trial lead. Uses clinical and disease state knowledge to make recommendations for methods and strategy for data cleaning approach.
- Collaborate with other functions to successfully support the planning and execution of clinical studies. Provides independent leadership of all areas requiring clinical input with oversight from the assigned Clinical Trial Lead/Medical Lead, and provides innovative and quality solutions for assigned problems and tasks.
- Provides clinical input and strategic recommendations for the planning and implementation of assigned clinical trial(s) including investigator selection, patient recruitment, feasibility questionnaire, training PowerPoints, and supporting Ethics committee submissions.
- Contributes to the strategic planning, preparation, and review of clinical documents (Protocol, ICFs, CSR, investigator brochure). May lead certain documents or sections of documents, including incorporation of input from other cross-functional team members.
- Provides clinical input and strategic recommendations for regulatory documents needed for all stages of assigned trial lifecycle (IND documentation, HA briefing books, BLAs, and Orphan Drug Applications).
- Responsible for clinical portions of key data management/statistical documents (eg: Case Report Forms, edit checks, data review plan and reports).
- Contribute to the planning and execution of external meetings and internal stakeholder meetings (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations. May have a speaking role on meetings when appropriate.
- Supports their manager when asked to contribute to harmonization between clinical trials and process improvement initiatives.
- Typically, the clinical research scientist may have the authority to make decisions related to issuing data cleaning queries and can decide whether there is a need to escalate for further discussion with the medical lead. They may also be delegated tasks from the clinical trial lead/medical lead for which they have decision making authority e.g. comment resolution when leading document creation.
REQUIREMENTS
- At least a Bachelor's degree in life science discipline.
- Bachelor's degree with 4+ years'; or MS with 3+ years'; or PharmD/PhD with 2+ years of pharma experience in clinical development or related function.
- CAR-T cell therapy and/or hematology/oncology disease experience is a plus.
- Good interpersonal & communication skills, including oral, written and interpersonal.
- Ability to effectively manage conflicts and negotiations while providing impact and influence.
- Collaborative with the ability to operate across multiple geographies.
- Good leadership & organizational skills, analytical skills, and presentation skills.
- Creative problem-solving skills.
- Strong organizational and project management skill and the ability to multitask.
- Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
- Oncology Therapeutic Experience preferred.
- Excellent working knowledge of GCP, FDA and ICH Guidelines.
Li-JR1
Li-Onsite
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO STATEMENT
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
For information related to our privacy notice, please review: Legend Biotech Privacy Notice.
INTRODUCTION
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a Senior Clinical Research Scientist as part of the Clinical Development team based in Somerset, NJ.
ROLE OVERVIEW
The Clinical Research Scientist (CS) in Clinical Development is an important role in the company supporting the development and life cycle of drug development projects. The Clinical Research Scientist will work closely with the Clinical Trial Lead/Medical Lead and Clinical Trial Manager to design and implement clinical trial protocols and manage sites, CROs and other associated work. In addition, the CS will support their manager to ensure program consistency & alignment across studies, working closely with cross-functional teams for achieving project goals, within timelines & with high quality. This clinical scientist will support early phase drug development in hematology/oncology.
KEY RESPONSIBILITIES
- Responsible to ensure the data review and cleaning activities meet the quality standards to support database locks in collaboration with data management and medical lead/clinical trial lead. Uses clinical and disease state knowledge to make recommendations for methods and strategy for data cleaning approach.
- Collaborate with other functions to successfully support the planning and execution of clinical studies. Provides independent leadership of all areas requiring clinical input with oversight from the assigned Clinical Trial Lead/Medical Lead, and provides innovative and quality solutions for assigned problems and tasks.
- Provides clinical input and strategic recommendations for the planning and implementation of assigned clinical trial(s) including investigator selection, patient recruitment, feasibility questionnaire, training PowerPoints, and supporting Ethics committee submissions.
- Contributes to the strategic planning, preparation, and review of clinical documents (Protocol, ICFs, CSR, investigator brochure). May lead certain documents or sections of documents, including incorporation of input from other cross-functional team members.
- Provides clinical input and strategic recommendations for regulatory documents needed for all stages of assigned trial lifecycle (IND documentation, HA briefing books, BLAs, and Orphan Drug Applications).
- Responsible for clinical portions of key data management/statistical documents (eg: Case Report Forms, edit checks, data review plan and reports).
- Contribute to the planning and execution of external meetings and internal stakeholder meetings (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations. May have a speaking role on meetings when appropriate.
- Supports their manager when asked to contribute to harmonization between clinical trials and process improvement initiatives.
- Typically, the clinical research scientist may have the authority to make decisions related to issuing data cleaning queries and can decide whether there is a need to escalate for further discussion with the medical lead. They may also be delegated tasks from the clinical trial lead/medical lead for which they have decision making authority e.g. comment resolution when leading document creation.
REQUIREMENTS
- At least a Bachelor's degree in life science discipline.
- Bachelor's degree with 4+ years'; or MS with 3+ years'; or PharmD/PhD with 2+ years of pharma experience in clinical development or related function.
- CAR-T cell therapy and/or hematology/oncology disease experience is a plus.
- Good interpersonal & communication skills, including oral, written and interpersonal.
- Ability to effectively manage conflicts and negotiations while providing impact and influence.
- Collaborative with the ability to operate across multiple geographies.
- Good leadership & organizational skills, analytical skills, and presentation skills.
- Creative problem-solving skills.
- Strong organizational and project management skill and the ability to multitask.
- Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
- Oncology Therapeutic Experience preferred.
- Excellent working knowledge of GCP, FDA and ICH Guidelines.
Li-JR1
Li-Onsite
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO STATEMENT
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
For information related to our privacy notice, please review: Legend Biotech Privacy Notice.
See all 230+ H-1B Visa Senior Clinical Research Scientist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Senior Clinical Research Scientist Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Senior Clinical Research Scientist
Align your credentials to specialty occupation
Your degree field must directly relate to clinical research science, not just life sciences broadly. A biochemistry or pharmacology degree supporting a clinical trials role reads cleaner to USCIS than a general biology degree for the same position.
Verify prevailing wage before salary negotiations
Use the OFLC Wage Search to look up the Level II or III prevailing wage for your SOC code and target metro area. Your offered salary must meet or exceed this figure for the LCA to be certified by DOL.
Target employers with active LCA filing history
Search Migrate Mate to identify pharma and biotech companies that have filed LCAs for clinical research scientist roles. Employers with recent filing history are already familiar with the process and less likely to pull an offer over sponsorship complexity.
Clarify CRO versus sponsor employer structure early
Contract research organizations bill clients for your time, which can complicate the H-1B employer-employee relationship USCIS scrutinizes. Confirm whether the CRO or the pharma sponsor is the H-1B petitioner before accepting an offer.
Request premium processing for protocol-driven timelines
Clinical trial start dates are rarely flexible. If your role ties to a protocol launch or IND filing, ask your employer to file Form I-907 for premium processing so USCIS adjudicates within 15 business days instead of several months.
Document protocol authorship and regulatory submissions
Gather copies of protocols you authored, IND or NDA submissions you contributed to, and any IRB correspondence listing you as a named researcher. These materials strengthen the specialty occupation argument in your I-129 petition.
H-1B Visa Senior Clinical Research Scientist: Frequently Asked Questions
Does a Senior Clinical Research Scientist role qualify as an H-1B specialty occupation?
Yes. Senior Clinical Research Scientist positions require a bachelor's degree or higher in a directly related field such as pharmacology, biochemistry, or clinical sciences, which meets the USCIS specialty occupation standard. The role's requirement for specialized scientific judgment in protocol design and data interpretation reinforces that qualification. You can verify the occupational requirements through O*NET to support your petition.
Which types of employers sponsor H-1B visas for clinical research scientists?
Pharmaceutical companies, biotechnology firms, medical device manufacturers, and contract research organizations are the most active H-1B sponsors for this role. Academic medical centers with industry-funded trial units also file regularly. You can browse companies with verified LCA filing history for clinical research positions on Migrate Mate, which filters employers by role type and sponsorship activity.
How does the H-1B cap lottery affect clinical research scientist roles at CROs?
Most CROs are subject to the annual H-1B cap and lottery. If you aren't selected, some CROs can place you with a cap-exempt institution such as a nonprofit research hospital or university, which can file outside the lottery. Confirm whether your CRO has existing relationships with cap-exempt affiliates before registration opens each March.
Can I switch employers during an active clinical trial without losing H-1B status?
Yes, under H-1B portability rules you can start working for a new employer once they file a non-frivolous H-1B transfer petition, without waiting for USCIS approval. Your original status remains valid during adjudication. However, if your role is tied to a specific IND or protocol as the named investigator, the transition may create regulatory continuity issues beyond the immigration question.
What happens to my H-1B status if my clinical trial is terminated early?
If your employer ends your position before your H-1B period expires, you enter a 60-day grace period during which you can find a new sponsoring employer. A new employer must file an H-1B transfer petition before that window closes. If your trial termination is foreseeable, start identifying prospective employers through Migrate Mate early so you don't lose time during the grace period.