Associate Director Clinical Operations

Associate Director, Clinical Operations

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 an Associate Director of Clinical Operations to support the planning, execution, and management of global clinical trials across multiple therapeutic programs. This individual will be responsible for operational oversight of assigned studies and will work collaboratively across internal teams and external vendors to ensure successful clinical trial delivery.

The Associate Director will contribute to study execution, vendor management, and process optimization within a dynamic and fast-paced biotech environment. The ideal candidate is detail-oriented, proactive, and experienced in managing clinical trial operations across global studies.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Clinical Trial Management

• Manage day-to-day operational activities for global Phase I–III clinical trials
• Support study startup, enrollment, maintenance, and closeout activities
• Track study timelines, milestones, risks, and budgets
• Ensure studies are conducted in compliance with protocols, SOPs, ICH/GCP guidelines, and applicable regulations

Vendor Oversight

• Oversee CROs, consultants, and functional vendors supporting clinical trial execution
• Review vendor deliverables and ensure adherence to timelines and quality expectations
• Participate in vendor selection, budgeting, and contract review activities

Cross-Functional Collaboration

• Collaborate with Clinical Development, Biometrics, Regulatory, Safety, and other functional teams
• Support development of operational plans and study execution strategies
• Facilitate effective communication across internal and external stakeholders

Operational Support & Process Improvement

• Support development and refinement of Clinical Operations processes and SOPs
• Assist in maintaining TMF quality and inspection readiness activities
• Contribute to operational metrics tracking and continuous improvement initiatives

Other duties as assigned

REQUIRED QUALIFICATIONS

• Bachelor’s degree in life sciences or related field required
• 8 years of Clinical Operations experience within biotech or pharmaceutical industries
• Experience supporting or managing global clinical trials
• Strong understanding of ICH/GCP and global clinical trial regulations
• Experience managing vendors and CRO relationships
• Ability to work effectively in a fast-paced, collaborative environment

PREFERRED QUALIFICATIONS

• Advanced degree preferred
• Experience in oncology, immunology, or related therapeutic areas preferred
• Experience working within emerging biotech organizations preferred
• Exposure to global clinical trial execution across multiple regions preferred

Competencies / Core Skills

• Strong organizational and project management skills
• Excellent communication and collaboration abilities
• Detail-oriented with strong problem-solving capabilities
• Ability to manage competing priorities effectively
• Strong operational execution mindset
• Adaptability and flexibility in a dynamic 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 hiring@Fortvitabio.com. 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.