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Full-Time

Senior Clinical Trial Manager

Confirmed live in the last 24 hours

Arcellx

Arcellx

51-200 employees

Develops cell therapies for cancer, autoimmune diseases

Biotechnology
Healthcare

Compensation Overview

$185k - $200kAnnually

+ Annual Bonus + Equity (RSU) Grant + Relocation Assistance

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 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

24%

1 year growth

26%

2 year growth

78%
Simplify Jobs

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.