Vice President – Clinical Operations

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🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $310k - $365k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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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

• Provide strategic operational oversight and execution of one or more complex global clinical programs across the ophthalmology and/or broader portfolio • Plan and execute clinical trials with high-quality, inspection-ready data on time and within budget • Lead Clinical Operations teams responsible for study execution • Partner with Clinical Science, Medical, Regulatory, Data Sciences, Clinical Compliance, Quality, Business Operations, Pharmacovigilance, and Technical Operations • Identify and mitigate operational risks, optimize trial performance, and drive executional excellence across Phase 1–3 clinical development • Lead, mentor, and develop Clinical Operations leaders • Represent Clinical Operations on cross-functional program teams and escalate critical issues to executive leadership • Provide executive oversight of CROs and strategic vendors • Oversee study budgets, forecasts, change orders, and resource planning • Drive inspection readiness and adherence to GCP, SOPs, regulatory requirements, and quality standards • Develop scalable operational processes, governance, KPIs, and operational metrics • Use data and performance analytics to support decision-making, resource planning, and study execution • Drive standardization, accountability, and continuous process improvement

🎯 Requirements

• Bachelor's degree in a scientific, business or health-related discipline • 15+ years of Clinical Operations experience in biotechnology or pharmaceutical development • Significant experience leading global Phase 1-2 and/or Phase 3 clinical trials • Experience participating in regulatory authority inspections supporting global clinical development programs • 6+ years of people leadership, including managing senior Clinical Operations leaders • Demonstrated success overseeing large global programs or multiple concurrent studies with significant operational complexity • Demonstrated success leading complex global Phase 1-3 clinical trials • Proven ability to lead multiple Clinical Operations trial teams across concurrent programs • Strong systems thinking and ability to design scalable processes supporting organizational growth • Experience using metrics, dashboards, operational analytics, and performance data to drive decisions and outcomes • Experience implementing process improvements that increase efficiency, quality, and execution predictability • Experience leading global CROs and strategic vendor partnerships • Excellent leadership, coaching, and organizational development skills • Ability to influence cross-functional teams without direct authority • Executive presence, concise communication, and strong decision-making skills • Deep knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations • Ophthalmology (retina) clinical development experience strongly preferred

🏖️ Benefits

• Base salary compensation range of $310,000 - $365,000 • Travel: 5%