Associate Director, Clinical Operations

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $179k - $205k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

Consulting • Manufacturing • Biotechnology

4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.

📋 Description

• Partner with the Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines • Provide operational leadership for the direction, planning, execution, and interpretation of clinical trials and data collection • Develop and monitor clinical trial and program timelines, budgets, risks, and mitigation plans • Guide and mentor Clinical Trial Managers and junior team members • Oversee day-to-day activities of Clinical Trial Operations and Clinical Data Management groups • Collaborate with Finance/Business Operations on budget planning, reviews, and re-forecasts • Design, implement, and oversee clinical vendor outsourcing strategy • Participate in vendor selection and governance committees • Ensure clinical trials remain inspection ready and are actively managed by cross-functional Study Execution Teams • Serve as Clinical Operations subject-matter expert on product cross-functional core teams as needed • Partner with Quality to maintain inspection readiness • Collaborate with Regulatory Affairs and Clinical Sciences on regulatory submissions and compliance requirements • Address escalated study issues and develop risk mitigation plans • Coordinate development and maintenance of clinical SOPs and review cross-functional SOPs and documents • Support development and review of protocols, amendments, study documents, plans, and operational execution • Participate in CRO, site, and vendor selection; monitor progress and trigger contingency plans as appropriate • Contribute to Clinical Operations processes and procedures and manage clinical resources for effective trial implementation

🎯 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 • Ophthalmology/Retina experience required • Relevant experience in clinical trial execution across all phases • Proven ability to recruit, retain, organize, and motivate clinical operations personnel • Ability to communicate updates and priorities to Clinical Operations and Development Leadership and advocate for required budget and resources • Ability to manage and oversee programs with corporate-wide impact • Ability to develop and manage functional and clinical trial-specific budgets • Ability to prioritize and manage a large volume of work with attention to detail • Strong interpersonal skills • Thorough knowledge 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 • Ability to write clearly and summarize information effectively • Ability to present complex information to various audiences • Ability to travel approximately 20%, or as trial needs demand • Ability to perform the stated sedentary-work and repetitive-motion physical requirements