Exec Director Clinical Development

Hybrid (Palo Alto Office)

Remote (Outside of the SF Bay Area)

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 Biologics is seeking an accomplished physician drug developer and people leader to join us as Executive Director, Clinical Development. In this highly visible role, you will provide strategic and operational leadership for one or more clinical-stage and/or preclinical biologic programs, guiding assets from early development through regulatory submission and toward potential commercialization.

You will be accountable for shaping and executing integrated clinical development strategies across one or more disease areas, ensuring alignment with scientific rationale, regulatory expectations, and long-term commercial objectives. As a core member of Fortvita’s development leadership team, you will play a central role in advancing transformative therapies for patients with serious and underserved diseases.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Develop, refine, and execute comprehensive clinical development strategies for Fortvita’s biologic programs, from first-in-human studies through late-stage development and regulatory submissions.
• Provide scientific and medical leadership across all aspects of clinical development, ensuring programs are data-driven, operationally efficient, and aligned with company objectives.
• Lead, mentor, and develop a high-performing clinical development organization, including managing multiple direct reports and potentially leading managers of managers.
• Oversee the design, execution, and interpretation of clinical trials, including protocol development, site selection, patient recruitment strategies, data quality, and regulatory compliance.
• Serve as a key clinical representative in interactions with global health authorities (e.g., FDA, EMA), leading and supporting regulatory discussions related to clinical development plans and trial execution.
• Analyze and interpret emerging clinical data to inform decision-making, risk assessment, and program prioritization.
• Manage timelines, resources, and budgets to ensure delivery of key milestones in a fast-paced, evolving development environment.
• Build and maintain strong relationships with investigators, key opinion leaders, CROs, and strategic partners.
• Partner closely with research, regulatory affairs, commercial, and finance teams to enable seamless program execution and enterprise-level decision-making.
• Stay current on scientific advances, competitive landscape, and evolving regulatory standards relevant to Fortvita’s therapeutic areas.
• Other duties as assigned

REQUIRED QUALIFICATIONS

• MD degree is required, with 13 years of experience in pharmaceutical or biotechnology clinical development, or equivalent academic experience at the Associate Professor level or higher.
• Formal training and/or significant clinical experience in rheumatology or dermatology, with demonstrated expertise in immune-mediated or inflammatory diseases.
• Proven success designing and executing multiple clinical trials as part of integrated clinical development programs.
• Demonstrated ability to author and present clinical development strategies for internal governance and senior-level decision-making.
• Deep understanding of GCP, ICH, FDA, EMA, and global regulatory requirements governing clinical research.
• Track record of leading health authority interactions and advancing investigational medicinal products through complex regulatory environments.
• Strong leadership presence with the ability to inspire, mentor, and align cross-functional teams.
• Exceptional analytical and strategic thinking skills, with sound judgment and comfort navigating trade-offs and competing priorities.
• Excellent written and verbal communication skills; experience publishing clinical trial results in peer-reviewed journals is required.
• Demonstrated ability to manage budgets, timelines, and external partners effectively.
• Passion for innovation and a deep commitment to improving patient outcomes.

PREFERRED QUALIFICATIONS

• Experience building or enhancing clinical development processes, systems, and operating models within a biotech or pharmaceutical organization.
• Track record of developing clinical strategies that resulted in label-enabling outcomes and supported commercialization.
• Direct experience submitting or supporting NDA, BLA, or MAA filings to global health authorities.
• Experience leading cross-functional teams through regulatory documentation, labeling strategy, and post-approval commitments.
• Exposure to Phase IV/post-marketing clinical development.
• Demonstrated ability to present compelling scientific and business cases to senior leadership and external stakeholders.
• Experience serving as an internal and external spokesperson for clinical programs.
• Strong collaborative mindset with experience working across research, development, commercial, legal, and business development teams to generate measurable outcomes.
• Proven courage, resilience, and effectiveness in navigating conflict and driving decisions in complex environments.

Competencies / Core Skills

• Communication
• Problem-solving
• Collaboration
• Time management
• Attention to detail

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.