Legend Biotech US is hiring a Senior Clinical Research Scientist to play a key role in our Clinical Development team. You will support the development and lifecycle of drug development projects, with a focus on early-phase programs in autoimmune indications.
What You'll Do
- Ensure data review and cleaning activities meet quality standards to support database locks.
- Collaborate with other functions to support the planning and execution of clinical studies.
- Provide clinical input and strategic recommendations for assigned clinical trials, including investigator selection, patient recruitment, and Ethics committee submissions.
- Contribute to the strategic planning, preparation, and review of clinical documents such as Protocols, ICFs, CSRs, and the investigator brochure.
- Provide clinical input for regulatory documents needed for all stages of the trial lifecycle, including IND documentation, HA briefing books, BLAs, and Orphan Drug Applications.
- Be responsible for clinical portions of key data management and statistical documents, including Case Report Forms, edit checks, data review plans, and reports.
- Contribute to the planning and execution of external and internal stakeholder meetings.
- Support harmonization between clinical trials and process improvement initiatives.
- Make decisions on issuing data cleaning queries and escalate as needed.
What We're Looking For
- A Bachelor’s degree or higher in a life science discipline.
- Bachelor’s degree with 4+ years’ experience; or MS with 3+ years’; or PharmD/PhD with 2+ years of pharma experience in clinical development or a related function.
- Good interpersonal and communication skills, both oral and written.
- Ability to effectively manage conflicts and negotiations while providing impact and influence.
- Collaborative nature with the ability to operate across multiple geographies.
- Strong leadership, organizational, analytical, and presentation skills.
- Creative problem-solving abilities.
- Strong organizational and project management skills with the ability to multitask.
- Computer literacy in MS Word, MS Excel, MS PowerPoint, and MS Project.
- Excellent working knowledge of GCP, FDA, and ICH Guidelines.
Nice to Have
- CAR-T cell therapy and/or autoimmune disease experience.
- Oncology Therapeutic Experience.
Technical Stack
- MS Word
- MS Excel
- MS PowerPoint
- MS Project
Team & Environment
You will be part of the Clinical Development team, working closely with the Clinical Trial Lead/Medical Lead and Clinical Trial Manager. This role reports to the Clinical Trial Lead/Medical Lead.
Benefits & Compensation
- Medical, dental, and vision insurance.
- 401(k) retirement plan with a company match that vests fully on day one.
- Eight (8) weeks of paid parental leave after just three (3) months of employment.
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
- Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans.
- Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.
- Compensation Range: $142,146—$186,567 USD.
Work Mode
This is a hybrid position based in Somerset, NJ.
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).
