Associate Scientific Director, Medical Affairs – Real World Evidence (RWE) Generation at Legend Biotech

United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell Therapy, ImmunotherapyIndustries

Requirements

Deep expertise in clinical research methodologies and study design
Strong collaborative approach with internal teams (Medical Affairs, Clinical Development, Regulatory Affairs, Commercial) and external/alliance partners (Integrated Evidence Team, Real World Value and Evidence teams)
Strategic and hands-on leadership skills for supervising RWE strategy and evidence generation
Authority to make decisions on direction, methodologies, approaches in evidence generation processes, project execution (timelines, milestones, resource allocation within budget); higher-level approvals needed for significant budget allocations

Responsibilities

Lead the development and execution of RWE generation to address evidence needs aligned with Legend Medical Affairs objectives, including formulating research questions, developing study protocols, and designing robust methodologies
Oversee all data generation activities, including MA-led Phase IV studies, RWE studies, Investigator Initiated Studies (IIS), and collaborative research; manage projects from strategy through execution and dissemination (internal and external)
Conduct annual data gap analyses to identify high-value medical affairs-driven studies and provide leadership in lifecycle evidence management, ensuring timely initiation and completion of prioritized studies
Manage project budgets, ensuring efficient resource allocation, vendor management, and timely delivery within financial parameters
Collaborate with internal teams (Clinical Development, Regulatory, Commercial) and external partners to maximize evidence generation and address emerging data needs
Oversee all aspects of study management, including enrollment, milestone tracking, and reporting progress to stakeholders
Represent Legend at internal and external meetings, congresses, workshops, investigator meetings, and other scientific engagements

Skills

Real World Evidence (RWE)

RWE Strategy

Evidence Generation

Clinical Research Methodologies

Study Design

Cross-Functional Collaboration

Medical Affairs

Lifecycle Management

Regulatory Affairs

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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