Full-Time

Director – Preclinical Project Development and Strategic Lead

Posted on 2/13/2025

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops and commercializes cell therapies

Compensation Overview

$188k - $246.7k/yr

+ Performance-based Bonus + Equity

Somerset County, NJ, USA

Hybrid

Category
Biology & Biotech (2)
,
Requirements
  • PhD in biology and biochemistry or related field
  • At least 10 years of relevant work experience, including a minimum of 5-8 years of preclinical research and development experience in pharmaceutical or biotech industry
  • Experience in IND submission of cell or therapies
  • Familiarity with preclinical drug development processes, regulatory guidelines, and GLP standards
  • Preclinical project lead in IND submission
  • Strong organizational and project management skills, with the ability to manage multiple projects simultaneously
  • Excellent communication and interpersonal skills for cross-functional collaboration and stakeholder engagement
  • Knowledge of regulatory requirements and preclinical study design principles
  • Experiences in preclinical research especially in cell therapy preclinical development is preferred
  • Experience working with CROs and managing external collaborations
  • Certification in project management (e.g., PMP, PRINCE2) is a plus
Responsibilities
  • Preclinical IND enabling study oversight
  • Work closely with program teams to develop preclinical IND strategies. Accountable for preclinical IND study delivery and quality
  • Developing and mange project plans, timelines, budgets and resources for preclinical IND programs
  • Coordinate and monitor preclinical studies, including in vitro and in vivo studies, ensuing alignment with program goals
  • Track project progress, identify risks and implement mitigation strategies to maintain timelines and deliverables
  • Cross functional collaboration
  • Serve as a liaison between internal departments (eg, research, toxicology, pharmacology, CMC, regulatory affairs) and eternal partners (e.g. CROs)
  • Facilitate communication and collaboration among multidisciplinary teams to achieve project milestones
  • Ensure preclinical studies comply with relevant regulatory guidelines (e.g., GLP, FDA, EMA).
  • Prepare or support the creation of regulatory submissions, including pre-IND packages and investigator brochures.
  • Data Management and Reporting
  • Oversee data collection, analysis, and documentation for preclinical studies.
  • Prepare project reports, presentations, and summaries for internal and external stakeholders.
  • Vendor and Budget Management
  • Identify, evaluate, and manage relationships with contract research organizations (CROs) and other external vendors.
  • Negotiate contracts, oversee budgets, and ensure high-quality deliverables from external partners.
  • Strategic Input
  • Contribute to the design and development of preclinical study strategies to support clinical translation.
  • Provide input on program development based on emerging data and scientific trends.
Desired Qualifications
  • None

Legend Biotech develops and commercializes cell therapies for serious diseases, including hematologic cancers and solid tumors, with a focus on personalized medicine. Its therapies, like CAR-T treatments, work by collecting a patient’s cells, engineering them to target cancer cells, expanding them, and reinfusing them into the patient. The company differentiates itself by using multiple technology platforms (technology-agnostic) and pursuing a broad pipeline, including exclusive global licenses for CAR-T therapies. Its goal is to bring effective, personalized cell therapies to market, improve outcomes for hard-to-treat cancers, and maintain transparent communication with investors while expanding globally.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Franklin Township, New Jersey

Founded

2014

Simplify Jobs

Simplify's Take

What believers are saying

  • CARVYKTI achieves profitability in 2025, company-wide profit by 2026.
  • Spain SNS approves reimbursement for second-line multiple myeloma in 2025.
  • CARTITUDE-5 enrollment completes, primary data expected 2026.

What critics are saying

  • Levi & Korsinsky investigates Legend Biotech for securities fraud since May 2025.
  • J&J's $1B Montgomery facility sidelines Legend's CARVYKTI manufacturing role.
  • MFN policy enforces US prices matching Germany's, slashing CARVYKTI reimbursements.

What makes Legend Biotech unique

  • CARVYKTI leads global CAR-T sales at $1.9B in 2025 across 14 markets.
  • Raritan facility supports 10,000 patients annually with 97-99% success rates.
  • MyCARVYKTI program covers patient travel, lodging, and meals 24/7.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Sick Leave

Paid Holidays

Remote Work Options

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

1%

2 year growth

2%
Yahoo Finance
Mar 10th, 2026
Legend Biotech's CARVYKTI hits $555M Q4 sales, reaches profitability with 10,000-dose capacity

Legend Biotech reported CARVYKTI net trade sales of approximately $555 million in Q4, up 66% year-over-year. Management said CARVYKTI reached profitability in 2025 and expects enterprise-wide profitability in 2026. The therapy is now available in 14 global markets across 294 treatment sites. Legend has installed manufacturing capacity for 10,000 doses, with plans to expand to 20,000 alongside Johnson & Johnson. Manufacturing success rates range from 97% to 99%. Clinical data show median progression-free survival of 50.4 months in triple-class-exposed patients with three prior lines of therapy. Approximately 65% of patients are now treated in the second-to-fourth-line setting, reflecting earlier use in the treatment course. Legend ended 2025 with $949 million in cash and recorded adjusted net income of $2.5 million in Q4.

Yahoo Finance
Mar 10th, 2026
Legend Biotech reports $1.9B CARVYKTI sales for 2025, treats over 10,000 patients

Legend Biotech reported CARVYKTI net trade sales of approximately $555 million in the fourth quarter and $1.9 billion for the full year 2025, achieving franchise profitability. The company has treated over 10,000 patients with its CAR-T therapy and expanded availability to 294 sites across 14 markets worldwide. The company completed expansion of its Raritan facility, creating the largest cell therapy manufacturing site in the United States with capacity to support 10,000 patients annually. Legend Biotech also advanced its pipeline, opening a 31,000-square-foot R&D facility in Philadelphia and dosing the first patient for its in vivo candidates. As of 31 December 2025, Legend Biotech held $949 million in cash and cash equivalents, providing financial runway beyond 2026 when it expects to achieve company-wide operating profit.

Yahoo Finance
Feb 3rd, 2026
Legend Biotech shares drop 46% in 3 months despite $72 fair value estimate

Legend Biotech has raised $120 million in a Series C round led by Ribbit Capital, valuing the pre-revenue AI startup at $1.45 billion. Sequoia and Kleiner Perkins participated, alongside new backer Emerson Collective, bringing total capital raised to $295 million. Co-founded by Robinhood CEO Vlad Tenev, Harmonic develops "Mathematical Superintelligence" that eliminates AI hallucinations by requiring outputs in verifiable Lean4 programming code. Its Aristotle model achieved top performance at the International Mathematical Olympiad in July. Founded in 2023, the company currently offers Aristotle via free API to mathematicians and researchers. It plans future commercialisation targeting safety-critical sectors including aerospace, automotive and finance, where error-free logic is essential.

BioSpace
Jan 29th, 2026
Biotech's Next Chapter: Asset-Centric Deals and Shifting Alpha at JPM 2026

Biotech's next chapter: asset-centric deals and shifting alpha at JPM 2026. January 29, 2026 | After years of contraction, investors see biotech reentering a growth cycle driven by scientific progress, asset quality and renewed conviction in oncology, obesity and neuroscience innovation. Now that the sound and fury of the J.P. Morgan Healthcare Conference have subsided, investors are taking a step back to evaluate for 2026 the acquisition and capital environment, the buzzy therapeutic spaces and lingering risk factors. Biotech is emerging from a multiyear slump into a new cycle driven by fundamental progress and late-stage assets, said Roderick Wong, managing partner and chief investment officer at New York-based RTW Investments. Although JPM 2026 felt light on headline megadeals, record-setting M&A rumors before the conference around Revolution Medicines (reported to be in talks with Merck and AbbVie) and Abivax (with Eli Lilly speculation takeover) underscored strong demand for high quality, late-stage development assets, Wong said. Actual announced deals (e.g., Eli Lilly - Ventyx Biosciences, GlaxoSmithKline - RAPT Therapeutics, Boston Scientific - Penumbra) reinforced that asset-centric transactions are with clear blockbuster or strategic potential are the most interesting, Wong said. From RTW's vantage point and reinforced by several VC conversations on the sidelines of JPM26, asset-focused companies remain more attractive than pure platform or technology plays in the current environment. Hot therapeutic investment spaces. Key disease areas of focus include oncology (pancreatic, breast, bladder), where several programs could reset standards of care and address major unmet needs, noted Stephanie Sirota, partner and chief business officer at RTW. Obesity is another major theme, with anticipation around the first true small-molecule pill from Eli Lilly and a next wave of novel mechanisms, Wong said. One of RTW's portfolio companies, Corxel, announced on January 23 a $287 million Series D fundraising. Neuroscience/CNS has seen a sharp sentiment shift, with investors leaning back into space after years of limited innovation, Wong and Sirota agreed. Their comments echo those heard on the sidelines of JPM26; that advances in biomarkers, brain mapping and AI, as well as a rapidly aging population, support investment in the space. Psychedelics exemplify a potential paradigm shift in depression treatment modality, Wong said, with Compass Pathways' Phase III data and a possible near-term launch supporting nondaily, episodic treatment models. The cultural and medical shift in psychedelic therapeutic is one of the topics explored in the RTW's latest book "Innovation is the Best Medicine." FDA remains a risk factor. The degree of policy risk for the biopharma sector has declined significantly since the start of the Trump administration last year, Wong said. At the time, major uncertainties surrounded tariffs, manufacturing reshoring and Most Favored Nations drug pricing negotiations. What has evolved are reasonable resolutions that have been neutral to modestly negative rather than worstcase scenarios, he added. There have been many discussions around the chaotic year at the FDA in 2025, including a revolving door of senior staff members. The main remaining structural risk, Wong said, is FDA behavior in "edge cases," particularly in rare diseases and emerging modalities like gene and cell therapies, using nontraditional trial designs, surrogate endpoints or single arm studies. Last year's players in this space saw negative feedback or rejection, discussed in greater depth in the RTW book. RTW is responding by being more conservative around such edge case programs, which it expects will depress capital flows into some rare disease and early modality assets. Alpha stacking model. The firm frames its investment process as "alpha stacking:" starting with rigorous fundamental equity analysis (science underwriting plus commercial forecasting) and layering on multiple, evolving sources of information and assessment, Sirota said. This includes collecting information on policy, considering transactional and operational models, as well as what is compelling from a buyer perspective. The firm has built deep therapeutic specialization plus functional expertise (e.g., IP, geography such as China) to move beyond headline-driven views of risk and opportunity. RTW has also invested internally in data science, automation and AI to enhance its research process, they agreed. Ultimately, investment is always evolving, Wong said. He noted that a scientific background at one was the advantage - an alpha - one had when investing, but that's become understood. Rather, alpha stacking is now about intentionally trying to understand where the advantages lie and staying on top of these evolving factors. In this episode of Denatured, Jennifer C. Smith-Parker speaks with RTW's Rod Wong and Stephanie Sirota how shifting JPM deal timing masks record M&A potential; why oncology, obesity, psychedelics, and neuroscience are attracting fresh capital; and how "alpha stacking" shapes their investment edge in an age of chronic uncertainty. January 29, 2026

Stock Titan
Aug 18th, 2025
[6-K] Legend Biotech Corporation American Current Report (Foreign Issuer)

On August 18, 2025, Legend Biotech Corporation announced the appointment of Carlos Santos as the Company's Chief Financial Officer ("CFO").

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