Senior Medical Director | Legend Biotech US | Remote (United States)

<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3"><strong class=" font-semibold">Company Information</strong></p>
<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3">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.</p>
<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3">Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson &amp; 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.</p>
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<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3">Legend Biotech is seeking <strong class=" font-semibold">Senior Medical Director</strong> as part of the <strong class=" font-semibold">Clinical Development</strong> team based <strong class=" font-semibold">Remotely in the US</strong>.</p>
<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3"><strong class=" font-semibold">Role Overview</strong></p>
<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3">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, &amp; Project Management. Core responsibilities will encompass developing &amp; 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 &amp; alignment across studies, working closely with cross functional teams for achieving project goals, within timelines &amp; with high quality. Candidate must possess passion for science and patients, as well as entrepreneurial drive to help the organization succeed.</p>
<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3"><strong class=" font-semibold">Key Responsibilities</strong></p>
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<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Development Plans (CDPs), clinical trials and protocols are properly designed and that they are executed in accordance with applicable Good Clinical Practice (GCP) regulations.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">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 &amp; strategic positioning is in line with company goals. Able to anticipate any potential delays/problems/challenges and establish mitigation plans and course corrections.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">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</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Lead &amp; author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs and clinical expert reports with high quality.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Clinical topics.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Responsible for the Clinical review of all adverse events and clinical data. Oversee medical review of data, query generation &amp; resolution.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">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 &amp; data management, business development, supply chain, etc.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Interaction with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Define project timelines &amp; deliverable, working closely with cross functional team and assure that they are consistent with company strategy &amp; commitments.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Assure that functional deliverable is completed on time, on budget and according to the highest quality, ethical and professional standards. Effective, consistent &amp; regular tracking of project timelines to allow full transparency to the senior leadership.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Lead the development of a significant clinical development budget and effectively manage resources, funding and expenses</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.)</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">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.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">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.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Prepare/oversee monthly progress reports and ad-hoc reports as required</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Represent Clinical function in cross functional activities</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Support process improvement and functional training at departmental &amp; company level</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Clinical leadership for business development and partnership activities as needed</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Assure that the highest quality, ethical &amp; professional values are demonstrated in all aspects of the teamwork</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations</span></li>
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<h3 class=" text-white font-semibold text-lg mb-2">Requirements</h3>
<ul class=" text-base sm:text-lg marker:text-color list-inside list-disc text-gray-500 list-disc list-outside pl-3 mb-6">
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">MD or MD-PhD or equivalent medical degree</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Oncology/Hematology &amp; CAR-T experience is highly desirable.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">5 or more years of pharmaceutical experience in Clinical Development.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Experience in leading registrational clinical studies</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Deep clinical knowledge, with medical practice experience.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Demonstrated skills in scientific analysis and reasoning.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Solid understanding of clinical development and epidemiology.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Sound knowledge of overall drug development process from discovery to registration and post marketing requirements &amp; surveillance.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Knowledgeable of competitive products and their application.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Strong track record of delivering results through effective team and peer leadership in matrix</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.)</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Excellent leadership &amp; organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.</span></li>
<li class=" leading-snug mb-2 pl-2"><span class="text-gray-200">Experience in biotech &#8211; preferred but not required.</span></li>
</ul>
<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3">#Li-LB1</p>
<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3">#Li-Remote</p>
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<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3">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 law.</p>
<p class=" text-gray-200 text-base sm:text-lg leading-relaxed mb-3">Legend Biotech maintains a drug-free workplace.</p>