Full-Time

Senior Clinical Trial Manager

Posted on 6/18/2024

Arcellx

Arcellx

51-200 employees

Develops immunotherapies for cell therapy

Biotechnology
Healthcare

Compensation Overview

$185k - $200kAnnually

+ Bonus + Equity Grant

Senior

San Carlos, CA, USA

Relocation assistance is offered if required.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Management
Quality Assurance (QA)
Requirements
  • BA/BS in science-related field with 8+ years’ relevant work experience in oncology trials, including prior experience as a study lead.
  • Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and regulatory requirements.
  • Exceptional project management skills, organization, 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
  • Oversees scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met.
  • Take a leadership role in the assigned study management activities, including development of critical study documents, including, but not limited to informed consent form templates, various management plans and study trackers.
  • Provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel.
  • Effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify quality metrics.
  • Anticipates obstacles or complex issues at the site, vendor, and study levels and implements solutions to achieve project goals or to overcome identified obstacles.
  • Proactively identify issues for escalation, participate in problem-solving and implementation of risk mitigation.
  • Lead other study activities as needed (e.g., site selection, start-up, recruitment, protocol deviation and TMF review).
  • Develop and ensure compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposes.
  • Review the quality and integrity of the clinical data through review of electronic CRF data.

Arcellx develops immunotherapies aimed at improving cell therapy for serious diseases. Their products focus on harnessing the body's immune system to fight illnesses. The company conducts research and clinical trials to create safe and effective treatments, which are then commercialized through partnerships and licensing agreements. Unlike many competitors, Arcellx emphasizes proprietary technology in its approach to cell therapy. The goal is to meet unmet medical needs by providing advanced treatment options for patients.

Company Stage

IPO

Total Funding

$194.5M

Headquarters

Gaithersburg, Maryland

Founded

2014

Growth & Insights
Headcount

6 month growth

16%

1 year growth

25%

2 year growth

66%
Simplify Jobs

Simplify's Take

What believers are saying

  • Partnership with Kite expands development and commercialization opportunities for anito-cel.
  • Robust long-term responses observed in CART-ddBCMA Phase 1 expansion trial.
  • Increasing interest in CAR-T therapies beyond oncology broadens market potential.

What critics are saying

  • Competition from established CAR-T therapies like Abecma and Carvykti may limit market share.
  • Dependency on Gilead's Kite partnership could pose risks if dynamics change.
  • Potential delays in Phase 3 iMMagine-3 trial could impact market entry timeline.

What makes Arcellx unique

  • Arcellx's CART-ddBCMA has FDA Fast Track, Orphan Drug, and RMAT designations.
  • The novel D-Domain binder in anito-cel enhances antigen binding and cell killing.
  • ARC-SparX offers dosable and controllable CAR-T therapy options for multiple diseases.

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