About this opportunity
Fortvita Biologics lists this Sr. Director Clinical Operations opportunity in palo alto, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs. Building on our foundation in oncology, we are expanding into cardiovascular and metabolic diseases, immunology, and ophthalmology, applying our scientific rigor and platform capabilities to areas of growing global health burden. Our expertise covers antibody discovery and engineering, including monoclonal, bispecific, and polyspecific antibodies, as well as antibody-drug conjugates, all supported by development strategies rooted in thoughtful design and agile execution.
Our clinical development footprint covers the U.S., Australia, and key regions across APAC and Europe, including the EU, UK, South Korea, and Japan. With more than 100 professionals across research, development, regulatory, and operations, we bring deep expertise and a global perspective to every program. Guided by our mission to transform research breakthroughs into therapeutic excellence and driven by our vision to improve lives through scientific innovation, we are committed to delivering meaningful impact for patients around the world.
POSITION SUMMARY
Fortvita is seeking a strategic and execution-focused Sr. Director of Clinical Operations to build, lead, and scale a predominantly in‑house clinical operations model. This leader will be responsible for the end‑to‑end delivery of global clinical trials, minimizing reliance on full‑service CROs and instead leveraging a hybrid model of internal capabilities supplemented by functional vendors.
The SD Clinical Operations will establish operational infrastructure, develop internal capabilities, and ensure trials are executed with speed, quality, and cost‑efficiency. This role requires a hands‑on leader who thrives in a fast‑paced biotech environment and has successfully implemented or operated within an in‑house or CRO‑lite clinical model.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
Define and execute the Clinical Operations strategy aligned with a lean, in‑house execution model
Build, mentor, and lead a high‑performing internal Clinical Operations team
Establish scalable infrastructure, processes, and systems to support global clinical development
Serve as a key member of the Development leadership team, contributing to overall portfolio strategy
Clinical Trial Execution
Oversee the end‑to‑end execution of global clinical trials (Phase I–III) in compliance with ICH/GCP, FDA, EMA, and global regulations
Ensure studies are delivered on time, on budget, and with high quality
Drive operational excellence across study startup, conduct, and closeout activities
Design and operationalize an in‑house clinical trial execution framework, reducing dependency on full‑service CROs
Determine optimal functional outsourcing strategy (e.g., data management, monitoring, biometrics)
Build internal capabilities across study management, vendor oversight, site management, and trial execution
Implement tools, systems, and KPIs to support internal delivery
Oversee selection and management of functional service providers and specialty vendors
Negotiate contracts, scopes of work, and budgets aligned with a non‑CRO‑led model
Ensure vendor performance through clear metrics, governance, and accountability
Cross‑Functional Collaboration
Partner with Clinical Development, Regulatory, Biometrics, CMC, and other functions to ensure seamless study execution
Provide operational input into protocols, study design, and development plans
Lead risk identification and mitigation planning across programs
Quality & Compliance
Establish and maintain SOPs, work instructions, and best practices
Drive inspection readiness and ensure compliance with global regulatory requirements
Implement risk‑based quality management approaches
Operational Excellence
Develop and track KPIs, metrics, and dashboards for study and team performance
Drive continuous improvement initiatives across Clinical Operations
Ensure effective communication of study status, risks, and mitigation plans to executive leadership
Other duties as assigned
REQUIRED QUALIFICATIONS
Bachelor’s degree in life sciences or related field (required)
12+ years of progressive experience in Clinical Operations within biotech or pharmaceutical companies
5 years of leadership experience, including building and leading teams
Demonstrated success delivering global clinical trials across multiple phases
Deep knowledge of global clinical development and regulatory requirements (FDA, EMA, ICH/GCP)
PREFERRED QUALIFICATIONS
Advanced degree (MS, PhD, MBA) preferred
Direct experience operating in or building an in‑house / CRO‑lite clinical operations model strongly preferred
Experience in oncology, immunology, or related therapeutic areas preferred
COMPETENCIES/CORE SKILLS
Strong strategic thinking with hands‑on execution capability
Proven ability to build infrastructure, processes, and high‑performing teams
Expertise in vendor strategy, governance, and performance management
Excellent communication, leadership, and stakeholder management skills
Ability to thrive in a fast‑paced, evolving biotech environment
Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.
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Worksite address
palo alto, CA, 94306, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.