Vice President Clinical Operations

Job description

Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next-generation biologics from concept to clinic. At Fortvita, you’ll have the opportunity to make a meaningful impact on patients’ lives worldwide while working in a collaborative, mission-driven environment.

POSITION SUMMARY

Fortvita is seeking a strategic and execution-focused Vice President 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 VP 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

Travel up to 20%

REQUIRED QUALIFICATIONS

Bachelor’s degree in life sciences or related field (required)

15+ years of progressive experience in Clinical Operations within biotech or pharmaceutical companies

7 years of leadership experience, including building and leading teams

Demonstrated success delivering global clinical trials across multiple phases

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

Deep knowledge of global clinical development and regulatory requirements (FDA, EMA, ICH/GCP)

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

BENEFITS

Competitive base salary, bonus, and equity for all employees

401(k) retirement plan with employer matching contributions

Comprehensive medical, dental, and vision insurance

Generous paid time off policy, including company holidays and floating holidays

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.

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I‑9 upon hire.

Employment at Fortvita is at‑will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

Employment may be contingent upon successful completion of a background check and any other requirements permitted by law.

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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.