Senior Medical Director (Remote)

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 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.
• 5 or more years of pharmaceutical experience in Clinical Development.
• 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.

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