Vice President, Clinical Operations
Summary
Leads global clinical-trial operations for a biotech developing gene therapies, overseeing Phase 1–3 studies, CROs, budgets, and inspection readiness to deliver high-quality, regulatory-compliant data.
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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
General Summary:
Vice President, Clinical Operations is responsible for strategic operational oversight and execution of one or more complex global clinical programs across the ophthalmology and/or broader portfolio. Reporting to the Chief Clinical Operations Officer, this role ensures clinical trials are planned and executed with excellence, delivering high-quality, inspection-ready data on time and within budget.
The VP provides leadership to Clinical Operations teams responsible for study execution and partners closely with cross-functional development teams, including Clinical Science, Medical, Regulatory, Data Sciences, Clinical Compliance, Quality, and Business Operations, to proactively identify and mitigate operational risks, optimize trial performance, and drive executional excellence across Phase 1–3 clinical development.
The VP fosters a culture of operational excellence by building scalable systems, standardized processes, and performance metrics that enable predictable execution, informed decision-making, and continuous improvement. This leader creates an environment where decisions are driven by objective data and operational metrics rather than individual effort.
Major Duties and Responsibilities:
Clinical Trial Execution & Oversight
- Provide operational leadership and oversight for one or more large global clinical development programs or multiple phase 1-2 clinical studies from study start-up through database lock.
- Ensure clinical trials are executed according to timelines, quality standards, budget, and corporate objectives.
- Lead Clinical Operations teams to proactively identify risks, develop mitigation plans, and resolve operational challenges.
- Ensure consistent execution of operational strategy across studies while maintaining inspection readiness.
- Drive study performance through key operational metrics and continuous improvement initiatives.
Leadership & Team Management
- Lead, mentor, and develop Clinical Operations leaders (Senior Directors, Directors, CTMs) responsible for study execution.
- Foster a culture of accountability, collaboration, operational excellence, and continuous improvement.
- Build organizational capability through coaching and talent development.
Cross-functional Leadership
- Partner with Clinical Science, Regulatory, Data Sciences/Medical, Clinical Compliance, Quality, Pharmacovigilance, and Technical Operations to ensure seamless trial execution.
- Represent Clinical Operations on cross-functional program teams.
- Escalate critical operational issues and recommend solutions to executive leadership.
Vendor & Financial Oversight
- Provide executive oversight of CROs and strategic vendors supporting assigned programs.
- Partner with Clinical Compliance to establish and maintain risk-proportionate sponsor oversight of vendors and delegated trial activities, ensuring documented oversight processes, issue escalation, and continuous evaluation of performance and compliance.
- Partner with Clinical Outsourcing and Business Operations to ensure vendor performance, governance, and accountability.
- Oversee study budgets, forecasts, change orders, and resource planning.
Operational Excellence
- Drive inspection readiness across assigned programs.
- Ensure adherence to GCP, SOPs, regulatory requirements, and quality standards.
- Develop and implement scalable operational processes and governance that improve execution efficiency, consistency, and inspection readiness.
- Establish and monitor key performance indicators (KPIs) and operational metrics to proactively identify risks, measure performance, and drive continuous improvement.
- Utilize data and performance analytics to support operational decision-making, resource planning, and study execution.
- Drive a culture of operational excellence through standardization, accountability, and continuous process improvement.
Core Competencies
- Demonstrated success leading execution of complex global Phase 1-3 clinical trials.
- Proven ability to lead multiple Clinical Operations trial teams across concurrent programs.
- Strong systems thinker with the ability to design scalable processes that support organizational growth.
- Demonstrated ability to leverage metrics, dashboards, and operational analytics to drive performance and informed decision-making.
- Experience implementing process improvements that increase efficiency, quality, and execution predictability.
- Ability to translate operational data into actionable insights and measurable business outcomes.
- 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 with concise communication and strong decision-making skills.
- Deep knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations.
Qualifications:
- 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.
- Ophthalmology (retina) clinical development experience strongly preferred.
- Demonstrated success overseeing large global programs or multiple concurrent studies with significant operational complexity.
Travel: 5%
Physical Requirements and Working Conditions:
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $310,000 - $365,000
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.