Senior Director, Clinical Operations at Arcellx

Redwood City, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

Candidates must possess a Bachelor’s degree in a scientific or health-related field and a minimum of 12 years of oncology clinical operations experience within the pharmaceutical or biotechnology industry. Strong knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines is required, along with excellent leadership, organizational, and communication skills.

Responsibilities

As the Senior Director, Clinical Operations, the individual will drive the successful execution of clinical trials, overseeing internal teams and CROs, providing strategic operational leadership, and managing financial planning, resource allocation, and department initiatives. This role will involve owning program oversight, mitigating risks, leading and mentoring teams, evaluating and managing vendors and clinical trial sites, overseeing budgetary activities, implementing quality checks, and providing technical expertise for clinical documents.

Skills

Clinical Operations

Clinical Trials

CRO Management

Budgeting

Financial Planning

Forecasting

Resource Planning

Program Management

Strategic Leadership

Department Initiatives

Leadership

Cell Therapy

Biotechnology

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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