Associate Director, Clinical Operations

🔥 20 hours ago

🇺🇸 United States – Remote

💵 $179k - $196k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies. We have built a deep portfolio of genetic medicine product candidates, with five product candidates in clinical trials for seven patient populations.

📋 Description

• Partner with Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines • 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 • 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 • Independently oversee day-to-day activities of the Clinical Trial Operations and Clinical Data Management groups • 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 • Ensure that each clinical trial is always inspection ready • Ensure that each clinical trial is being actively managed by a cross-functional Study Execution Team (SET) • May sit on product cross-functional core teams as Clinical Operations SME • Partner closely with Quality to ensure that the programs and 4DMT always remain inspection ready • Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (eg, Clinicaltrials.gov) • Addresses escalated study issues in collaboration with CTMs and senior management as appropriate inclusive of risk mitigation plans • Coordinates the development and maintenance of clinical SOPs as pertains to the program and provides review/input into cross-functional SOPs and other documents • Supports development and review of protocols/amendments, study documents and plans, and operational execution • 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 • Contributes to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials.

🎯 Requirements

• B.S./B.A. in Life Science or related discipline required • Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred • Clinical Research certification preferred, but not required • 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 • Requires late phase trial experience • Proven ability to recruit, retain, organize, and motivate clinical operations personnel • Ability to communicate to Clinical Operations and Development Leadership team updates and priorities as well as to advocate for required budget and resources • Ability to manage and oversee programs that have corporate-wide impact • Ability to develop and manage functional and clinical trial-specific budgets • Must be self-motivating; prioritize and manage a large volume of work; show attention to detail • Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical trials and business performance • Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials • Ability to be flexible and adaptable to changing business needs • Excellent communication and interpersonal skills • Must be able to write clearly and summarize information effectively • Must be able to present complex information to various audiences

🏖️ Benefits

• 4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.