Full-Time

Associate Director – Sr. Clinical Research Scientist

Posted on 5/28/2024

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops cell therapies for cancer treatment

Biotechnology

Senior

Somerset County, NJ, USA

Required Skills
Communications
Management
Word/Pages/Docs
Google Cloud Platform
Excel/Numbers/Sheets
PowerPoint/Keynote/Slides
Requirements
  • Bachelor’s degree with 8+ years’; or MS with 7+ years’; or PharmD/PhD with 6+ years of pharma experience in clinical development or a related field
  • CAR-T cell therapy 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
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 leads.
  • Collaborate with other functions to successfully lead, plan and execute clinical studies.
  • Responsible to provide expert clinical input and strategic decision-making for the planning and implementation of assigned clinical trial(s) including investigator selection, patient recruitment, clinical portion of feasibility questionnaire, training PowerPoints, and supporting Ethics committee submissions.
  • Lead the preparation and review of all clinical documents in partnership with medical director (Protocol, ICFs, CSR, investigator brochure).
  • Responsible to provide expert clinical input and strategic decision-making 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 and proactively seeks to harmonize across programs and make process improvements (eg: Case Report Forms, edit checks, data review plan and reports)
  • Contribute significantly to the clinical strategy outlined in the Global Clinical Development Plan (CDP) for compounds in clinical development or new clinical entities, working closely with medical lead and other stakeholders and cross functional teams.
  • Lead in planning and execution of external meetings and internal stakeholder meetings in partnership with medical director, and shares speaking role for meetings (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations.
  • Expected to represent CS function in cross functional activities and contribute to harmonization between clinical trials and process improvement initiatives

Legend Biotech specializes in developing and manufacturing novel cell therapies for hematologic malignancies and solid tumors, leveraging cutting-edge technologies to deliver advanced treatment options for patients worldwide. The company's pipeline of cell therapies includes agents targeting diseases considered intractable and incurable, with a focus on transforming the world of oncology and medicine.

Company Stage

IPO

Total Funding

$750.5M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

19%

1 year growth

50%

2 year growth

137%