Executive Director, Early Clinical Development

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 Early Clinical Development as part of the Clinical Development team based in Somerset NJ.

Role Overview

The Executive Director of Early Clinical Development is a critical role in the company with significant impact on the development and life cycle of drug development projects. The candidate for this role will be responsible to lead the Early Clinical Development Team for IND submission and the design execution and oversight of first-in-human dose finding clinical trials. Full understanding of tenets of FIH studies (e.g. dose selection rationale biomarker plans etc.) and the relevant compliance framework for clinical development activities are essential. Candidate must possess passion for science and patients as well as entrepreneurial drive to help the organization succeed.

Key Responsibilities

• Lead clinical science aspects of design execution interpretation and reporting of early (first in human) stage clinical trials.
• Collaborate with scientists and technical experts to integrate cellular therapy specific aspects of PK/PD diagnostic and biomarker plans into the overall clinical development strategy.
• Contribute clinical leadership and expertise in the development of study protocols and clinical study reports study medical monitoring safety reporting regulatory documentation and interactions and other clinical deliverables.
• Collaborate with academic scientists clinical experts and study investigators.
• Represent and advocate for the project in internal and external venues.
• Clinical leadership for business development and partnership activities as needed.
• Act as a champion for high standards of compliance ethics and safety and putting patients first.

Requirements

• MD or MD-PhD or equivalent medical degree with US board certification in hematology and/or oncology.
• 6 years industry/ academic clinical development experience in hematology/oncology leading cross-functional development teams is required.
• Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable.
• Experience in biotech - preferred but not required.
• Demonstrated capacity to think creatively when addressing complex situations
• Demonstrated excellence and experience in first-in-human clinical development including the design execution of first in human trial and submission of INDs.
• Experience leading pre-IND and IND meetings with health authorities is highly desirable.
• Excellent communication and leadership skills; willingness to roll up the sleeves to contribute to team efforts in a dynamic fast-paced environment; stellar writing skills a track record of publications; superb presentation skills
• Able to anticipate biometrics regulatory clinical operations development sciences pharmacovigilance and other development needs to ensure successful program delivery
• Ability to communicate effectively with cross functional teams such as pre-clinical scientists clinical operations safety-PV biomarker biostatistics regulatory and project management including peer to peer interactions with academic scientific experts KOLs and stake holders.
• Assure that the highest quality ethical & professional values are demonstrated in all aspects of the team work
• Ensures compliance with corporate policies and procedures as well as all related healthcare laws and regulations
• Highly collaborative & effective influencing skills and the ability to operate across multiple geographies
• Strong track record of delivering results through effective team and peer leadership in matrix
• Superior interpersonal skills & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence. Communicate regularly and effectively with senior leaders.
• Excellent leadership & organizational skills analytical skills presentation skills and strong experience in translating medical/clinical information into clinical development strategies.
• Travel requirement up to 15-20 % 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.