Director, Clinical Operations

Director Clinical Operations

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 highly motivated and operationally strong Director of Clinical Operations to support the execution and oversight of global clinical trials across multiple development programs. This individual will play a key role in driving study execution, vendor oversight, and cross-functional coordination within a lean and agile clinical development environment.

The Director of Clinical Operations will oversee clinical trial activities from study startup through closeout while ensuring compliance with regulatory requirements, timelines, budgets, and quality standards. The ideal candidate is a collaborative leader with strong project management capabilities and hands-on operational experience in global clinical development.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Clinical Trial Execution

• Lead and oversee the operational execution of Phase I–III global clinical trials
• Ensure studies are conducted in compliance with ICH/GCP guidelines and applicable regulatory requirements
• Drive study startup activities including feasibility, site selection, enrollment planning, and vendor onboarding
• Monitor study timelines, budgets, risks, and deliverables to ensure successful execution
• Oversee study closeout activities and ensure inspection readiness

Vendor & CRO Management

• Manage CROs, functional service providers, and specialty vendors to ensure high-quality performance
• Review scopes of work, budgets, contracts, and change orders
• Establish vendor governance processes and performance metrics
• Ensure timely issue escalation and resolution across vendors and partners

Cross-Functional Collaboration

• Partner closely with Clinical Development, Regulatory Affairs, Biometrics, Medical Writing, Pharmacovigilance, and CMC teams
• Provide operational input into study protocols, development plans, and timelines
• Facilitate communication across internal and external stakeholders to ensure alignment and execution efficiency

Leadership & Operational Excellence

• Mentor Clinical Trial Managers and support development of internal operational capabilities
• Contribute to the development and improvement of SOPs, processes, and operational standards
• Support implementation of scalable systems, tools, and KPIs to optimize trial execution
• Drive continuous improvement initiatives across Clinical Operations

Quality & Compliance

• Ensure inspection readiness and support audits and regulatory inspections
• Maintain high standards for documentation, TMF quality, and compliance activities
• Support implementation of risk-based quality management practices

Other duties as assigned

REQUIRED QUALIFICATIONS

• Bachelor’s degree in life sciences or related field required
• 10+ years of Clinical Operations experience within biotech or pharmaceutical industries
• Demonstrated experience managing global clinical trials across multiple phases
• Must have oncology experience
• Strong knowledge of FDA, EMA, ICH/GCP, and global clinical trial regulations
• Experience managing CROs and external vendors
• Proven ability to manage multiple studies and priorities in a fast-paced environment

PREFERRED QUALIFICATIONS

• Advanced degree (MS, MBA, PhD) preferred
• Experience in oncology, immunology, or related therapeutic areas preferred
• Prior experience in emerging biotech or lean operational environments strongly preferred
• Experience supporting global studies across the U.S., APAC, and Europe preferred

Competencies / Core Skills

• Strong leadership and project management skills
• Excellent organizational and operational execution capabilities
• Strong communication and stakeholder management skills
• Ability to work independently while collaborating cross-functionally
• Strategic thinker with strong attention to detail
• Ability to thrive in a fast-paced and 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 . 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.