Sr. Director Clinical Operations

Fortvita Biologics; Palo Alto (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

Fortvita Biologics in Palo Alto is seeking a Sr. Director of Clinical Operations to lead and scale an in-house clinical operations model. The role involves overseeing end-to-end execution of global clinical trials and building a high-performing team. Candidates should possess over 12 years of experience in clinical operations within biotech environments and a strong understanding of regulatory requirements. This position aims to enhance operational efficiency and ensure high-quality clinical trial delivery.

Qualifications

• 12+ years of progressive experience in Clinical Operations within biotech or pharmaceutical companies.
• 5 years of leadership experience, including building and leading teams.
• Deep knowledge of global clinical development and regulatory requirements (FDA, EMA, ICH/GCP).

Responsibilities

• Define and execute Clinical Operations strategy aligned with a lean, in‑house execution model.
• Build, mentor, and lead a high‑performing internal Clinical Operations team.
• Ensure studies are delivered on time, on budget, and with high quality.

Skills

Leadership

Project Management

Clinical Operations Strategy

Regulatory Knowledge

Education

Bachelor’s degree in life sciences or related field

Advanced degree (MS, PhD, MBA)

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.