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Full-Time

Associate Director

Clinical Operations

Posted on 4/5/2024

Arcellx

Arcellx

51-200 employees

Develops cell therapies for cancer, autoimmune diseases

Hardware
Biotechnology

Senior

North Bethesda, MD, USA + 1 more

Category
Healthcare Administration & Support
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Communications
Management
Requirements
  • BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent)
  • 8+ years of clinical operations experience, including some experience with early phase research design
  • Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and regulatory requirements
  • Exceptional project management skills, organizational and problem-solving skills
  • Eager to learn with a collaborative, team-oriented mindset
  • Excellent written and verbal communication skills with an ability to express complex ideas to study personnel at research and clinical institutions
Responsibilities
  • Overseeing scope, quality, timelines, and budget for early-stage autoimmune clinical trial
  • Leading site and study management activities, including development of critical study documents
  • Providing study-specific training and leadership to clinical research staff
  • Effectively communicating expectations to CRO, ensuring appropriate site management, holding CRO accountable to timelines, and verifying quality metrics
  • Anticipating obstacles or complex issues at the site, vendor, and study levels, and implementing solutions
  • Proactively identifying issues for escalation, participating in problem-solving and implementation of risk mitigation
  • Developing and ensuring compliance with clinical monitoring plan
  • Reviewing the quality and integrity of clinical data through review of electronic CRF data
  • Working with CRO/sites to resolve data queries

Arcellx develops innovative cell therapies for cancer and autoimmune diseases, leveraging their novel D-Domain technology and transformative ddCAR and ARC-SparX platforms to enhance cell therapy.

Company Stage

N/A

Total Funding

$736M

Headquarters

Gaithersburg, Maryland

Founded

2014

Growth & Insights
Headcount

6 month growth

5%

1 year growth

13%

2 year growth

63%
INACTIVE