Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a Medical Director as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Clinical Research Physician (CRP) is a critical role in the company with significant impact on the development and life cycle of drug development projects. The Clinical Research Physician will provide strategic leadership to develop Clinical Development Plan (CDP), working closely with partners in Pre-Clinical, Regulatory, Safety, Medical Affairs, Translational Development, Market Access, Stats, & Project Management. Core responsibilities will encompass developing & implementing the Clinical Development Plan and providing leadership to new product development from IND to submission and managing the Clinical Research Scientists, if applicable. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Candidate must possess passion for science and patients, as well as entrepreneurial drive to help the organization succeed. If assigned to a co-development program, the CRP will serve as the Legend medical lead on the assigned trial and will be expected to provide strategic leadership to ensure overall high quality in the execution of the clinical trial and foster good collaboration with the co-development partner.

Key Responsibilities

Development Plans (CDPs), clinical trials and protocols are properly designed and that they are executed in accordance with applicable Good Clinical Practice (GCP) regulations.
The CRP will be leading the Clinical program focused on various indications and will exhibit a passion for Phases 1 through 3 studies, including biomarkers, proof-of-concept and full development trials. Also, ensure that the priorities & strategic positioning is in line with company goals. Able to anticipate any potential delays/problems/challenges and establish mitigation plans and course corrections.
Provide therapeutic area medical and scientific expertise to study teams and key stakeholders. Work with cross functional team members to prepare abstract, manuscripts and presentation for external meetings
Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning.
Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision.
Lead & author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs and clinical expert reports with high quality.
Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Clinical topics.
Responsible for the Clinical review of all adverse events and clinical data. Oversee medical review of data, query generation & resolution.
The CRP will also partner with therapeutic area leads in other functions, such as discovery, regulatory affairs, safety, medical affairs, health economics, biostatistics & data management, business development, supply chain, etc.
Interaction with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.
Define project timelines & deliverable, working closely with cross functional team and assure that they are consistent with company strategy & commitments.
Assure that functional deliverable is completed on time, on budget and according to the highest quality, ethical and professional standards. Effective, consistent & regular tracking of project timelines to allow full transparency to the senior leadership.
Lead the development of a significant clinical development budget and effectively manage resources, funding and expenses.
Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.)
Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization. Work closely with a key strategic alliance partner for projects that are being jointly developed.
Identify project risks with input from the cross functional teams, and support resolving issues. Ensure that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership.
Prepare/oversee monthly progress reports and ad-hoc reports as required.
Represent Clinical function in cross functional activities.
Support process improvement and functional training at departmental & company level.
Clinical leadership for business development and partnership activities as needed.
Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the teamwork.
Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations.

Requirements

MD or MD-PhD or equivalent medical degree.
Oncology/Hematology & CAR-T experience is highly desirable.
2 or more years of pharmaceutical experience in Clinical Development for Medical Director; 5 or more years of pharmaceutical experience in Clinical Development for Senior Medical Director.
Experience in leading registrational clinical studies.
Deep clinical knowledge, with medical practice experience.
Demonstrated skills in scientific analysis and reasoning.
Solid understanding of clinical development and epidemiology.
Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
Knowledgeable of competitive products and their application.
Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
Strong track record of delivering results through effective team and peer leadership in matrix
Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.)
Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.
Experience in biotech - preferred but not required.
Willingness to "roll up the sleeves" to contribute to team efforts in a dynamic, fast-paced environment.
Demonstrated ability in leading high-performing teams in a matrix and collaborative environment.
Excellent ability to communicate, specifically on Clinical and scientific topics.
Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence.
Highly collaborative & effective influencing skills and the ability to operate across multiple geographies.

#Li-JK1

#Li-Hybrid

The anticipated base pay range for this is: $248,615 - $341.846 USD.

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional 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 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.

EEO Statement

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.