Executive Director, Multiple Myeloma Pipeline Lead

Legend Biotech is a global biotechnology company dedicated to treating and one day curing life-threatening diseases. Headquartered in Bridgewater New Jersey we are advancing the next generation of cell therapy through a portfolio of innovative technologies including autologous allogeneic and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T) T-cell receptor (TCR-T) natural killer (NK) cell-based therapies and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites we are committed to discovering and developing safe effective and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking an Executive Director Multiple Myeloma Pipeline Leadas part of the Clinical Development team based in Somerset NJ.

Role Overview

The Executive Director Clinical Development will provide strategic scientific and medical leadership for Legend Biotechs Multiple Myeloma Pipeline. This individual will serve as the clinical lead for the Multiple Myeloma Pipeline and will be accountable for defining and executing an integrated clinical development strategy across a portfolio of assets and programs spanning early-stage and as appropriate late-stage development. The role includes leadership of first-in-human dose-escalation dose-expansion proof-of-concept and registration-enabling clinical studies across the pipeline. The Executive Director will collaborate closely with cross-functional teams to support pipeline prioritization asset differentiation regulatory strategy lifecycle planning and evidence generation. Responsibilities include supporting IND submissions and regulatory interactions; integrating translational biomarker pharmacology safety and clinical data; and providing strategic input into study design clinical operations and development decision-making.

Ultimately this individual will be responsible for generating high-quality clinical evidence that enables data-driven pipeline decisions supports benefit-risk assessments establishes competitive differentiation and advances programs toward registration and commercialization. The successful candidate will bring deep expertise in multiple myeloma strong clinical judgment experience advancing innovative cellular and immunotherapyplatforms and the ability to lead effectively in a highly matrixed fast-paced environment.

Key Responsibilities

• Serve as the clinical lead for the Multiple Myeloma Pipeline providing strategic scientific and medical leadership across the development lifecycle.
• Develop and maintain an integrated clinical development strategy across the Multiple Myeloma Pipeline ensuring alignment with corporate objectives scientific opportunities competitive positioning regulatory expectations and patient needs.
• Drive pipeline prioritization asset sequencing resource-allocation recommendations and development-stage decision-making across multiple assets programs disease settings and lifecycle opportunities.
• Develop and execute integrated clinical development plans including disease-setting and line-of-therapy strategy patient population selection endpoint strategy dose-selection rationale sequencing and combination strategy biomarker and measurable residual disease strategy safety monitoring approach and evidence-generation plans.
• Lead the design execution monitoring interpretation and reporting of first-in-human dose-escalation dose-expansion proof-of-concept and other early clinical studies.
• Lead or contribute to late-stage clinical development activities as appropriate including pivotal-study strategy comparator and endpoint selection protocol design data interpretation and registration-enabling planning.
• Establish clear data-driven advancement pause and termination criteria for pipeline assets and provide recommendations to governance committees based on emerging clinical translational regulatory operational and competitive evidence.
• Identify opportunities to differentiate and expand the Multiple Myeloma Pipeline through novel targets treatment modalities rational combinations sequencing strategies and lifecycle-management approaches.
• Partner with Research Translational Science Business Development Commercial and Corporate Strategy colleagues to evaluate internal and external opportunities and optimize the strategic value of the Multiple Myeloma Pipeline.
• Contribute clinical and scientific expertise to business development evaluations due diligence activities licensing opportunities alliance discussions and strategic partnership assessments relevant to the Multiple Myeloma Pipeline.
• Provide clinical leadership for protocols clinical study reports Investigators Brochures regulatory briefing documents IND submissions health authority meeting packages publications abstracts presentations and other key clinical deliverables.
• Provide medical and scientific oversight for study conduct including medical monitoring eligibility review safety review dose-escalation decision-making data review and interpretation of emerging clinical data.
• Integrate clinical translational biomarker pharmacology safety real-world and competitive intelligence data into clinical development decisions and pipeline strategy.
• Ensure development plans reflect contemporary regulatory expectations for oncology drug development including robust dose optimization PK/PD integration biomarker-informed decision-making patient-centered endpoints and clear benefit-risk assessment.
• Partner closely with Translational Science Biomarkers Pharmacology Nonclinical Development Regulatory Affairs Safety/Pharmacovigilance Biostatistics Data Management Clinical Operations Project Management CMC Commercial and Market Access colleagues to ensure integrated and executable development plans.
• Lead cross-functional pipeline and governance discussions and present recommendations trade-offs risks and investment options to senior leadership and portfolio-review committees.
• Identify and proactively manage clinical regulatory scientific operational safety competitive and strategic risks across the Multiple Myeloma Pipeline including development of appropriate mitigation and contingency plans.
• Engage with investigators academic experts cooperative groups study sites patient advocacy organizations and external advisors to support high-quality execution scientific exchange enrollment strategy and visibility within the multiple myeloma community.
• Represent the Multiple Myeloma Pipeline in internal governance forums senior leadership reviews external scientific meetings advisory boards regulatory interactions and business development or partnership discussions as needed.
• Lead develop and mentor the Multiple Myeloma Pipeline Clinical Development Team including Medical Directors Clinical Scientists and matrixed clinical development personnel as appropriate.
• Champion a culture of patient focus scientific rigor collaboration innovation urgency accountability ethics compliance and operational excellence.

Requirements

• MD MD-PhD or equivalent medical degree required; board certification in hematology or oncology is required.

• Minimum of 6 years of clinical development experience in the biopharmaceutical industry and/or academic medicine with substantial experience in hematologic malignancies and multiple myeloma.

• Substantial expertise in multiple myeloma clinical development is strongly preferred including experience across relapsed/refractory and earlier-line treatment settings.

• Demonstrated experience designing and leading early clinical development programs including first-in-human studies dose escalation dose expansion dose selection integrated safety monitoring clinical data review and proof-of-concept generation.

• Demonstrated experience leading or significantly contributing to a clinical development pipeline containing multiple assets programs indications or lifecycle-management opportunities is highly desirable.

• Experience supporting pipeline governance asset prioritization resource-allocation discussions investment decisions and strategic development planning is highly desirable.

• Experience with cell therapy CAR-T in vivo cell therapy T-cell engagers bispecific antibodies antibody-drug conjugates protein degraders or other innovative therapies relevant to multiple myeloma is strongly preferred.

• Experience contributing to IND submissions pre-IND or IND meetings regulatory briefing packages and health authority interactions is highly desirable.

• Strong understanding of multiple myeloma clinical development including International Myeloma Working Group response criteria measurable residual disease assessment safety monitoring benefit-risk evaluation dose optimization biomarker strategy and clinical development decision-making.

• Experience leading or significantly contributing to cross-functional development teams in a matrixed global environment is preferred.

• Ability to translate complex medical scientific translational regulatory commercial and competitive information into clear pipeline strategies and actionable development plans.

• Excellent written and verbal communication skills including experience developing clinical and regulatory documents presenting to senior leaders and governance committees and engaging external experts and investigators.

• Strong collaboration influencing conflict-management negotiation and decision-making skills with the ability to align stakeholders across functions geographies and levels of the organization.

• Demonstrated ability to anticipate and integrate needs from Clinical Operations Regulatory Affairs Safety/Pharmacovigilance Biometrics Translational Science Project Management CMC Commercial Market Access and other development functions.

• Track record of delivering results in a fast-paced environment with the ability to operate strategically while contributing hands-on when needed.

• Commitment to the highest standards of quality ethics compliance patient safety and professional conduct.

• Ability to travel up to 1520% of the time.

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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations we participate in the E-Verify program. If you are selected for employment you will be required to complete the Form I-9 process and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair transparent and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race color creed religion national origin ancestry citizenship status age sex or gender (including pregnancy childbirth related medical conditions and lactation) gender identity or gender expression (including transgender status) sexual orientation marital status military service and veteran status disability genetic information or any other protected characteristic under applicable federal state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.