STEM OPT Senior Clinical Research Scientist Jobs
Senior Clinical Research Scientist roles in biotech, pharma, and academic medical centers qualify for the 24-month STEM OPT extension when your employer is enrolled in E-Verify. A STEM degree in life sciences, biomedical engineering, or a related CIP-coded field is required to qualify. You have up to 36 months total to build clinical trial experience and transition to long-term 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 83+ STEM OPT Senior Clinical Research Scientist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new STEM OPT Senior Clinical Research Scientist Jobs.
Get Access To All JobsTips for Finding STEM OPT Authorization as a Senior Clinical Research Scientist
Verify your degree qualifies by CIP code
Pull your degree's Classification of Instructional Programs code from your transcript or DSO and cross-check it against the DHS STEM Designated Degree Program List. Degrees in biochemistry, biomedical sciences, or pharmacology typically qualify, but interdisciplinary programs sometimes use non-STEM CIP codes that disqualify you.
Filter employers by E-Verify enrollment status
Pharmaceutical companies, contract research organizations, and hospital systems are not automatically E-Verify participants. Confirm enrollment through the E-Verify employer search before accepting any offer, since your STEM OPT extension is void without it.
Build your I-983 training plan around protocol-specific tasks
Your I-983 must list concrete learning objectives tied to your STEM degree, not just your job title. For a Senior Clinical Research Scientist role, map objectives to protocol development, pharmacokinetics analysis, or regulatory submissions so the plan withstands a USCIS site visit.
Target sponsors with active IND or BLA filing history
Use the OFLC Wage Search to identify employers who have filed Labor Condition Applications for clinical research scientist roles in your target geography. Companies with active Investigational New Drug or Biologics License Applications are structurally set up for long-term visa sponsorship and already work with immigration counsel.
Use Migrate Mate to find E-Verify employers hiring now
Search Migrate Mate for Senior Clinical Research Scientist roles filtered by E-Verify enrollment and STEM OPT eligibility. The platform surfaces employers with verified sponsorship history so you're not cold-applying to companies that can't legally employ you on an OPT extension.
Time your H-1B registration around your OPT end date
If you're approaching your 24-month STEM OPT extension window, confirm your employer will register you in the H-1B lottery before April 1 of the relevant fiscal year. Cap-gap protection only applies if a timely H-1B visa petition is filed while your OPT EAD remains valid.
Frequently Asked Questions
Does a Senior Clinical Research Scientist role qualify for the STEM OPT extension?
Yes, if your degree is in a STEM-designated field such as biological sciences, biomedical engineering, pharmacology, or a related discipline listed on the DHS STEM Designated Degree Program List. The role itself must also relate directly to your degree field. Your DSO will confirm CIP code eligibility when you apply for the extension through SEVIS.
Does my employer need to be enrolled in E-Verify to hire me on STEM OPT?
Yes. E-Verify enrollment is a federal requirement for any employer hiring a STEM OPT student on the 24-month extension. You can confirm enrollment through the E-Verify employer search before signing an offer. If the employer is not enrolled, they must complete enrollment before your STEM OPT extension is approved and before you begin work.
What goes into the I-983 training plan for a clinical research role?
The I-983 must describe how your work as a Senior Clinical Research Scientist directly relates to your STEM degree. List specific objectives such as designing clinical protocols, analyzing trial data, preparing regulatory submissions, or managing investigational product accountability. Generic job descriptions are not sufficient. Both you and your supervisor sign the form, and USCIS may audit it during a site visit.
What happens to my work authorization if my H-1B is selected but not yet approved when my OPT expires?
Cap-gap protection extends your OPT EAD automatically if your employer files a timely H-1B cap-subject petition before your OPT end date and you are selected in the lottery. Your authorization continues through September 30 of that fiscal year. If the H-1B is denied or withdrawn, the cap-gap period ends and you must stop working immediately.
Where can I find Senior Clinical Research Scientist jobs with employers who sponsor STEM OPT?
Migrate Mate lists Senior Clinical Research Scientist positions filtered by employers enrolled in E-Verify and with verified sponsorship history, so you can focus your applications on companies that can legally extend your work authorization. Searching by role and location on Migrate Mate removes the guesswork of identifying STEM OPT-compatible employers in pharma, biotech, and CRO settings.