Executive Director, Multiple Myeloma Pipeline Lead

Job description

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 Lead** as 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 Biotech’s 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, Investigator’s 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 15–20% of the time. #Li-AS1 #Li-Hybrid The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Pay Range (Base Pay): $294,483—$386,511 USD **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. For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](https://legendbiotech.com/privacy-notice/).