Medical Director at Arcellx

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

Medical Doctor (M.D.) or non-US equivalent of M.D. degree with hematologic malignancy experience in an academic or hospital environment
Completion of a residency program and oncology focused subspecialty fellowship strongly preferred
5+ years of relevant clinical trial experience in the pharmaceutical industry, academia, or equivalent, including regulatory submission support, medical writing oversight for trial related documents, and strategic vision including understanding of the field, knowledge of competitive landscape, and network of academic investigators
Well-honed communication skills with the ability to collaborate effectively with cross-functional teams

Responsibilities

Contribute to the development and implementation of clinical development plans for cell therapy programs
Provide medical oversight and strategic input into study design, protocol development, and endpoint selection
Serve as the medical lead for clinical trials, including oversight of patient safety and adverse event management
Collaborate with clinical operations and pharmacovigilance teams to ensure effective medical monitoring and risk management
Interface with regulatory authorities on clinical development plans, study protocols, and data submissions
Contribute to the preparation of regulatory documents (e.g., IND/IMPD, BLA/MAA) and responses to inquiries
Analyze clinical trial data, interpret results, and contribute to the development of clinical study reports and publications
Work closely with biostatistics and data management teams to ensure robust data analysis and reporting
Collaborate with external experts, investigators, and advisory boards to gather insights and support clinical trial execution
Represent the company at scientific conferences, symposia, and external meetings
Partner with translational research, manufacturing, and regulatory affairs teams to integrate medical insights into program strategies
Collaborate with business development and commercial teams to support product positioning and market access strategies

Skills

Clinical Development

Study Design

Protocol Development

Endpoint Selection

Medical Monitoring

Safety Oversight

Cell Therapy

Immunotherapy

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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