Legend Biotech is a global, commercial-stage biotechnology company developing and manufacturing novel therapies. We explore and apply innovative technologies to deliver cutting-edge options for patients around the world.

Our corporate headquarters is located in Somerset, NJ, and our manufacturing footprint includes facilities in the United States, China and the Belgium.

Industry: Biotechnology Research
Company Size: 1,001-5,000 employees

Legend Biotech

Savvy Admin PROD

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.

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a 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 such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay): : $127,313 USD - $167,099 USD

**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.

Senior Clinical Research Scientist

Galvanize Therapeutics is developing therapies to deliver life-changing healthcare solutions to patients and their doctors at the convergence of biology, engineering, and care delivery.

Industry: Medical Equipment Manufacturing
Company Size: 51-200 employees

Galvanize Therapeutics, Inc.

**About Galvanize Therapeutics**

Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.

**About The Role**

The Clinical Research Scientist provides broad analytic support for Clinical Affairs activities including developing, implementing, and managing data collection, data analyses, and other activities that optimize analytical efficiency and depth. This role involves collaborating closely with team members to assist in extracting insights from clinical study data and contribute to writing reports and manuscripts.

**Qualifications**

**Education and Training**

- Minimum of a bachelor’s degree in Life Sciences, Computer Science, Data Analytics, or related analytical fields.

- Advanced degree (MS, PhD) preferred.

- Minimum of 3 years of relevant work experience.

**Skills And Experience**

- Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.

- Experience working with a variety of datasets and preparing reports.

- Knowledge of data analysis applications (e.g., Excel, Power BI, GraphPad Prism, R, Python).

- Knowledge of and experience with digital pathology and histological image analysis preferred, including experience with image analysis software.

- Understanding of cancer biology and immuno-oncology is preferred.

- Experience in the medical device industry and/or oncology clinical trials is preferred.

**Other Qualifications**

- Strong analytical skills, problem-solving, writing, communication, and interpersonal skills.

- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.

- Able to work independently and in a team environment, with attention to detail and in an efficient manner.

- Experience with data visualization software is preferred.

**What You'll Do**

- Develop and implement image analysis tools to analyze histologically stained tissue, and develop scalable analytical workflows to support clinical research.

- Manage and optimize sample and data collection workflows and integration of sample metadata including from clinical study sites, external labs. Responsible for data receipt and organization. Plan timelines for these activities to meet business needs.

- Collaborate with cross-functional teams, such as clinical operations, medical affairs, regulatory affairs, research and development, and commercial/marketing, as needed to understand clinical team and business requirements and translate to optimal analytics output.

- Contribute to the ongoing analysis of clinical study data (e.g., histology image analysis), including data interpretation, data visualization, analysis using statistical techniques, and report generation.

- Assist with project management within the clinical affairs department, including clinical research vendor identification and management.

- Prepare data and results in a variety of formats for manuscript development and presentations. Contribute to writing reports and manuscripts and preparing presentations.

- Assist with communication of scientific and clinical findings to both internal and external stakeholders.

- Conduct and prepare literature reviews, as needed.Describe the specific responsibilities and job functions of the role

~~This role pays between ~~~~$110,000 and $115,000 ~~~~per year, and your actual base pay will depend on your location, skills, qualifications, and experience.~~

~~Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.~~

~~Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.~~

~~We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. ~~

Clinical Research Scientist

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