Associate Director, Clinical Operations
4D Molecular TherapeuticsAbout the role
<div class="content-intro"><p><strong><em>Attention recruitment agencies:</em></strong><em> All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.</em></p> <p> </p> <p>4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery</p></div><p><strong><u>GENERAL SUMMARY: </u></strong> </p> <p>The Associate Director, Clinical Operations will be responsible for implementation, execution and oversight of all clinical trials within a clinical program, in coordination with cross-functional project teams to ensure that assigned clinical trials are executed on time, within budget, and in compliance with GCP and other applicable guidelines and regulations. </p> <p><strong><u>MAJOR DUTIES & RESPONSIBILITIES:</u></strong> </p> <ul> <li>Partner with Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines </li> <li>Provide operational leadership to the direction, planning, execution and interpretation of clinical trials and data collection by effectively developing and monitoring clinical trial/program timelines, budgets, risks and mitigation plans </li> <li>Provides guidance and mentoring to Clinical Trial Managers (CTMs) and junior level team members in study document development, vendor and study management, study implementation, issue resolution, timelines, budgeting and resourcing</li> <li>Independently oversee day-to-day activities of the Clinical Trial Operations
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