Sr. Director, Clinical Operations

Fortvita Biologics; United States; Hybrid; USD 190,000 - 290,000; Full time

Job summary

Fortvita Biologics seeks a Sr. Director of Clinical Operations to build and scale a predominantly in-house clinical operations model. You will lead end-to-end global trials (Phase I–III) with a hybrid approach, delivering speed, quality, and cost efficiency.

The role requires 12+ years in Clinical Operations, 5+ years of leadership, and deep knowledge of FDA/EMA/ICH‑GCP. Travel up to 20% and a preference for a Palo Alto presence.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 12+ years in Clinical Operations within biotech or pharmaceutical companies.
• 5+ years of leadership, including building and leading teams.
• Proven success delivering global clinical trials across multiple phases.
• Deep knowledge of FDA, EMA, ICH/GCP standards and regulatory requirements.

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 portfolio strategy.
• Oversee end-to-end execution of global clinical trials (Phase I–III) in compliance with ICH/GCP, FDA, EMA.
• Drive vendor strategy, governance, and performance management to support non-CRO led model.
• Ensure trial delivery on time, on budget, and with high quality.

Skills

Strategic thinking

Leadership

Vendor governance

Stakeholder management

Project management

Biotech experience

Education

Bachelor’s degree in life sciences or related field

Tools

Clinical trial systems

Job description

Remote (U.S.-based) - CA, CO, CT, DC, FL, IL, IN, MA, MD, MN, MT, NH, NJ, NY, NC, PA, RI, TX, UT, VA, WA

Preference is Hybrid – Palo Alto office

Travel up to 20% required

ABOUT THE COMPANY

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.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

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 [e-mail]. 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.