Associate Director, Clinical Operations (Retina)

About this 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 and Clinical Data Management groups</li> <li>Collaborate with Finance/Business Operations on annual budget planning (external spend) as well as quarterly budget reviews and re-forecasts; designing, implementing, and overseeing clinical vendor outsourcing strategy; actively participating in the selection of vendors to support 4DMT clinical trials as well as active governance of them; participating and/or leading vendor governance committees</li> <li>Ensure that each clinical trial is always inspection ready</li> <li>Ensure that each clinical trial is being actively managed by a cross-functional Study Execution Team (SET)</li> <li>May sit on product cross-functional core teams as Clinical Operations SME</li> <li>Partner closely with Quality to ensure that the programs and 4DMT always remain inspection ready</li> <li>Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (eg, Clincialtrials.gov)</li> <li>Addresses escalated study issues in collaboration with CTMs and senior management as appropriate inclusive of risk mitigation plans</li> <li>Coordinates the development and maintenance of clinical SOPs as pertains to the program and provides review/ input into cross-functional SOPs and other documents</li> <li>Supports development and review of protocols/ amendments, study documents and plans, and operational execution</li> <li>Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate</li> <li>Contributes to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials. </li> </ul> <p><strong><u>QUALIFICATIONS:</u></strong><strong><u> </u></strong> </p> <p>Education: </p> <ul> <li>B.S./B.A. in Life Science or related discipline required </li> </ul> <ul> <li>Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred. </li> </ul> <ul> <li>Clinical Research certification preferred, but not required. </li> </ul> <p>Experience:  </p> <ul> <li>B.S./B.A. with 9+ years of industry experience in clinical development with a minimum of 3 years managerial experience, or M.A./M.S. with 4+ years of experience. </li> <li style="font-weight:…