STEM OPT Clinical Research Scientist Jobs
Clinical Research Scientist roles in biotech, pharma, and academic medical centers are strong fits for STEM OPT. Your STEM degree in biological sciences, chemistry, or a related field qualifies you for the 24-month extension, and employers in this space routinely use E-Verify, making the authorization process straightforward.
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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 384+ STEM OPT Clinical Research Scientist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new STEM OPT Clinical Research Scientist Jobs.
Get Access To All JobsTips for Finding STEM OPT Authorization as a Clinical Research Scientist
Verify your CIP code before applying
Check that your degree's Classification of Instructional Programs code falls within a STEM-designated field recognized by ICE. Life sciences, biochemistry, and biomedical engineering codes are typically covered, but applied health programs sometimes are not. Confirm with your DSO before your OPT end date.
Confirm E-Verify enrollment during outreach
Ask your recruiter directly whether the hiring entity, not just the parent company, is enrolled in E-Verify. Contract research organizations often use separate legal entities for different sites, and E-Verify enrollment must match the specific employer of record listed on your I-983.
Build an I-983 training plan around protocol milestones
Clinical Research Scientist roles map cleanly to STEM OPT training goals when you tie your I-983 learning objectives to specific trial phases, GCP compliance tasks, and data integrity responsibilities. Generic training plans draw more scrutiny from your DSO and USCIS during any review.
Target sponsors through DOL LCA disclosure data
Use Migrate Mate to filter employers who have filed Labor Condition Applications for research scientist roles. This surfaces companies with a documented history of supporting STEM OPT and later H-1B visa transitions, which matters when you're evaluating long-term authorization continuity.
Check prevailing wage tiers before negotiating offers
Run the OFLC Wage Search using SOC code 19-1042 to see Level I through Level IV wage bands for the metro area where the role is located. Offers below the Level I threshold signal an employer unlikely to clear DOL requirements for any future PERM or H-1B filing.
Time your cap-gap window around trial timelines
If your employer files an H-1B petition before your OPT expires, cap-gap protection extends your authorization through September 30 of the fiscal year. Clinical trial roles with fixed protocol schedules benefit from aligning your petition filing with enrollment milestones to avoid gaps mid-study.
Frequently Asked Questions
Does my STEM degree qualify me for the STEM OPT extension as a Clinical Research Scientist?
It depends on your specific CIP code, not your job title. Degrees in biological sciences, biochemistry, biomedical engineering, and chemistry are commonly STEM-designated and qualify. Degrees in public health, health administration, or clinical programs without a hard science core often do not. Confirm your CIP code with your DSO against the current ICE STEM Designated Degree Program List before assuming you're eligible.
Does every employer hiring Clinical Research Scientists use E-Verify?
Not automatically. Pharmaceutical companies and academic medical centers frequently maintain E-Verify enrollment, but smaller contract research organizations and startups sometimes do not. You must confirm that the specific legal entity employing you, not just a parent company or staffing firm, is enrolled in E-Verify before your STEM OPT extension is approved. Your DSO can't authorize the extension without that confirmation.
What should my I-983 training plan include for a Clinical Research Scientist role?
Your I-983 should connect your degree-level training to concrete on-the-job learning outcomes: protocol design, GCP compliance, adverse event documentation, statistical analysis, or regulatory submission support. Vague objectives like 'gain research experience' are routinely flagged. Map each goal to a skill area from your STEM degree and a specific deliverable in the role. USCIS expects a clear relationship between your coursework and your training activities.
How does cap-gap work if my Clinical Research Scientist employer files an H-1B petition?
If your employer submits a timely H-1B cap-subject petition before your OPT EAD expires, cap-gap automatically extends your work authorization through September 30. If USCIS selects and approves the petition, your H-1B status begins October 1. If the petition is not selected, your authorization ends September 30 and you must stop working. Cap-gap doesn't apply if the petition is filed after your EAD expires.
Where can I find Clinical Research Scientist jobs with E-Verify employers?
Migrate Mate filters job listings specifically for employers with STEM OPT authorization history, so you're not manually screening hundreds of postings for E-Verify status. Clinical Research Scientist roles in pharma, biotech, and CRO environments appear alongside employer filing records, which helps you prioritize companies already experienced with the STEM OPT process and more likely to support long-term sponsorship.