Senior Medical Director (Remote)

Company Information

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 and natural killer (NK) cell-based immunotherapy. 

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) in 2017. 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 Senior Medical Director as part of the Clinical Development team based Remotely in the US.  

Role Overview

The Senior Medical Director is a critical role in the company with significant impact on the development and life cycle of drug development projects. The Senior Medical Director 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.

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 Senior Medical Director 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 Senior Medical Director 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 o