Senior Clinical Trial Manager at Arcellx

Redwood City, California, United States

Arcellx Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, Cell TherapyIndustries

Requirements

Candidates must possess a BA/BS in a science-related field with at least 8 years of relevant work experience in oncology trials, including prior experience as a study lead. Strong knowledge of the clinical research process, all functional areas of clinical trials, and regulatory requirements is essential. Exceptional project management, organization, and problem-solving skills are required, along with a collaborative, team-oriented mindset and excellent written and verbal communication abilities.

Responsibilities

The Senior Clinical Trial Manager will oversee the scope, quality, timelines, and budget of clinical trials, ensuring project objectives are met by managing internal functional leads, CROs, and vendors. This role involves leading study management activities, providing study-specific training and leadership to clinical research staff, and anticipating and resolving complex issues at site, vendor, and study levels. Responsibilities include proactive issue identification, risk mitigation, leading activities such as site selection and recruitment, developing and ensuring compliance with the clinical monitoring plan, and reviewing clinical data quality and integrity.

Skills

Clinical Trial Management
Budget Management
Timeline Management
Vendor Management
Project Management
Communication
Regulatory Compliance

Arcellx

Develops immunotherapies for cell therapy

About Arcellx

Arcellx develops immunotherapies aimed at improving cell therapy for serious diseases. Their products focus on advanced techniques that enhance the effectiveness of treatments. The company collaborates with healthcare providers and research institutions to bring these therapies to patients. Unlike many competitors, Arcellx emphasizes proprietary products and partnerships to drive their research and development efforts. The goal is to meet unmet medical needs by providing safe and effective treatment options through their innovative approach to cell therapy.

Gaithersburg, MarylandHeadquarters
2014Year Founded
$194.5MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Unlimited Paid Time Off
Flexible Work Hours
401(k) Company Match
Fully-Paid Parental Leave
Tuition Reimbursement
Relocation Assistance

Risks

Competition from established CAR-T therapies like Abecma and Carvykti could limit market share.
Dependency on Gilead's Kite partnership poses risks if partnership dynamics change.
Phase 3 iMMagine-3 trial delays or failures could impact anito-cel's market timeline.

Differentiation

Arcellx's CART-ddBCMA has FDA Fast Track and Orphan Drug 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.

Upsides

Growing investment in personalized medicine aligns with Arcellx's tailored immunotherapies.
Advancements in gene editing like CRISPR enhance precision in engineered cell therapies.
Outpatient CAR-T administration could reduce costs and increase accessibility for Arcellx.

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