Vice President – Clinical Operations

🔥 0 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 operational leadership and oversight for large global clinical development programs or multiple Phase 1–2 studies from study start-up through database lock • Ensure clinical trials meet timelines, quality standards, budget, and corporate objectives • Lead Clinical Operations teams in identifying risks, developing mitigation plans, and resolving operational challenges • Maintain consistent execution of operational strategy and inspection readiness across studies • Drive study performance through operational metrics and continuous improvement • Lead, mentor, and develop Clinical Operations leaders • Partner with Clinical Science, Regulatory, Data Sciences/Medical, Clinical Compliance, Quality, Pharmacovigilance, and Technical Operations • 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 • Ensure adherence to GCP, SOPs, regulatory requirements, and quality standards • Develop scalable operational processes, governance, KPIs, and performance analytics to improve execution efficiency and decision-making

🎯 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 • Ability to design scalable processes supporting organizational growth • Experience using metrics, dashboards, and operational analytics to drive performance and decision-making • Experience implementing process improvements • Experience leading global CROs and strategic vendor partnerships • 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 • Remote work arrangement • Equal employment opportunities • 5% travel