Director of Clinical Operations

Franklin Township, New Jersey, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Candidates must have experience and knowledge of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, cellular/gene industry landscape, clinical trials operations, and FDA/ICH regulatory requirements. The ability to manage, mentor, and develop new clinical operation team members is also essential.

Responsibilities

The Director of Clinical Operations will lead the planning, management, and oversight of pipeline studies, taking ownership of all aspects of study conduct and CRO oversight. This role serves as a point of contact for clinical study project management, communications, and daily operations for clinical INDs. Responsibilities include collaborating with cross-functional teams, defining project timelines and deliverables, creating study project plans, and ensuring program consistency and operational excellence through process improvement.

Skills

Clinical Trial Management

CRO Oversight

Regulatory Requirements (FDA/ICH)

Clinical Drug Development

Project Management

Cross-functional Collaboration

Biotechnology

Pharmaceutical Industry

Legend Biotech

Develops and commercializes cell therapies

About Legend Biotech

Legend Biotech develops and commercializes cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.

Franklin Township, New JerseyHeadquarters

2014Year Founded

$146.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Sick Leave

Paid Holidays

Remote Work Options

Risks

Increased competition from Amgen's Imdelltra may impact CAR-T therapy focus.

Collaboration with Multiply Labs may face technological challenges, delaying production timelines.

Financial strain from new R&D facility could affect operational focus if advancements lag.

Differentiation

Legend Biotech focuses on novel cell therapies for oncology, including CAR-T and NK cells.

The company is technology agnostic, exploring multiple platforms for effective cancer treatments.

Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line use.

Upsides

Recent FDA and European approvals for CARVYKTI® expand its market reach in multiple myeloma.

New R&D facility in Philadelphia boosts innovation in next-generation cell therapies.

Alan Bash's appointment could accelerate CARVYKTI®'s growth and market penetration.

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