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Full-Time

Director – Clinical Data Management

Posted on 6/27/2024

Arcellx

Arcellx

51-200 employees

Develops cell therapies for cancer, autoimmune diseases

Hardware
Biotechnology

Compensation Overview

$230k - $250kAnnually

+ Bonus + Equity (RSU) Grant + Relocation Assistance

Expert

San Carlos, CA, USA

Category
Data Management
Data & Analytics
Required Skills
Data Analysis
Requirements
  • Minimum BA/BS in scientific or health-related field
  • 10+ years of clinical data management experience in pharma/biotech, with some oncology trial experience required
  • 3+ years of experience as a therapeutic program lead overseeing multiple clinical trials
  • Experience with different clinical systems, vendor management, regulatory guidelines, data visualization, analytics, and reporting tools
  • Strong organizational and communication skills
  • Ability to adapt quickly and manage multiple priorities in a fast-paced environment
Responsibilities
  • Lead Clinical Data Management for multiple products and/or indications
  • Direct the design and implementation of the CDM process with vendors
  • Oversee and evaluate vendors, including CRO data management activities
  • Collaborate with clinical development team to improve data management quality and efficiency
  • Lead development of standardized eCRFs
  • Manage reconciliation between EDC and non-EDC data
  • Coordinate activities to lock clinical databases
  • Lead the development and maintenance of SOPs and Work instructions related to CDM activities

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

16%

1 year growth

25%

2 year growth

76%
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Simplify's Take

What believers are saying

  • The Phase 3 iMMagine-3 trial for anito-cel could significantly boost Arcellx's market position if successful.
  • Recent robust long-term responses from the Phase 1 expansion trial of anito-cel indicate promising efficacy and safety, potentially leading to FDA approval.
  • The $285M equity investment and upfront cash from Kite provide substantial financial backing for Arcellx's ongoing and future projects.

What critics are saying

  • The competitive landscape for CAR T therapies is intense, with established players like Abecma and Carvykti posing significant challenges.
  • Regulatory hurdles, such as the recent FDA partial hold, could delay product development and market entry.

What makes Arcellx unique

  • Arcellx's anitocabtagene autoleucel (anito-cel) is the first BCMA CAR T therapy for multiple myeloma utilizing a novel D-Domain binder, setting it apart from existing treatments.
  • The company's strategic partnership with Kite, a Gilead Company, enhances its research capabilities and market reach, distinguishing it from smaller biotech firms.
  • Arcellx's focus on innovative immunotherapies for cancer and other incurable diseases positions it uniquely in the biotech landscape.
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