Vice President Clinical Development

LOCATION:

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

Preference is Hybrid - Palo Alto

Travel up to 30% required （Domestic & International）

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 executive to provide strategic and medical leadership for oncology clinical development programs supporting the Company's strategic partnerships. The Vice President will establish global clinical development strategies, provide medical leadership across development programs, and represent Fortvita in alliance governance, regulatory interactions, and external scientific engagements.

This executive will collaborate closely with cross-functional teams and strategic partners to ensure programs are scientifically rigorous, operationally efficient, and aligned with regulatory, clinical, and business objectives while advancing Fortvita's oncology portfolio.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Clinical Development Strategy

• Develop and execute integrated global clinical development strategies for oncology assets within Fortvita's strategic partnerships.
• Provide strategic leadership across all stages of clinical development, ensuring successful progression through key clinical, regulatory, and commercialization milestones.
• Develop clinical development plans aligned with scientific, regulatory, and commercial objectives.
• Evaluate emerging clinical data, competitive intelligence, evolving standards of care, and biomarker strategies to optimize development programs.
• Contribute to portfolio prioritization, lifecycle planning, indication expansion strategies, and investment decisions.
• Identify opportunities to accelerate development timelines while maintaining scientific rigor and patient safety.

Strategic Partnership Leadership

• Serve as Fortvita's senior clinical development representative for programs conducted under the Company's strategic partnerships.
• Represent Fortvita on Joint Steering Committees, alliance governance meetings, and executive reviews.
• Collaborate closely with strategic partners to align clinical development strategy, governance, timelines, and program execution.
• Build collaborative relationships that facilitate effective decision-making across partner organizations.
• Lead clinical discussions during governance meetings and executive-level program reviews.
• Resolve strategic and operational challenges throughout the development process.
• Ensure development milestones, contractual commitments, and partnership objectives are successfully achieved.

Clinical Leadership

• Serve as Clinical Lead for assigned oncology development programs.
• Provide medical oversight for global oncology clinical studies.
• Review efficacy, safety, PK/PD, biomarker, and translational medicine data to guide development decisions.
• Lead benefit-risk assessments and chair Clinical Development Team meetings.
• Review key clinical documents to ensure scientific quality and regulatory compliance.

Clinical Trial Design & Execution

• Lead protocol development and study design.
• Provide oversight of study endpoints, patient populations, biomarkers, adaptive designs, and statistical considerations.
• Partner with Clinical Operations to optimize study execution and delivery.
• Support study startup, enrollment strategies, interim analyses, database reviews, and Clinical Study Reports.
• Ensure compliance with GCP, ICH guidelines, and global regulatory requirements.

Medical Monitoring & Safety

• Provide strategic medical oversight throughout clinical development.
• Partner with Drug Safety and Pharmacovigilance on safety signal evaluation and benefit-risk assessments.
• Participate in Safety Review Committees and Data Monitoring Committees.
• Ensure patient safety remains central to all development decisions.

Regulatory Strategy

• Lead clinical interactions with FDA and other global health authorities.
• Contribute to INDs, CTAs, BLAs, NDAs, Investigator Brochures, Briefing Documents, and regulatory submissions.
• Ensure clinical development strategies align with evolving global regulatory expectations.

Scientific Leadership & External Engagement

• Represent Fortvita at scientific congresses, investigator meetings, advisory boards, and scientific forums.
• Develop relationships with Key Opinion Leaders, investigators, and academic collaborators.
• Present clinical data and development strategies to internal leadership, strategic partners, and external audiences.

Cross-Functional & People Leadership

• Partner with Clinical Operations, Biometrics, Regulatory Affairs, Translational Medicine, Drug Safety, Medical Affairs, Clinical Pharmacology, CMC, Commercial, and Business Development.
• Mentor physicians and Clinical Scientists while fostering scientific excellence, innovation, collaboration, and accountability.

Operational Excellence

• Ensure development programs are delivered on schedule, within budget, and in compliance with applicable regulations.
• Identify program risks and implement proactive mitigation strategies.
• Support strategic planning, resource planning, portfolio governance, and continuous improvement initiatives.

Other duties as assigned

REQUIRED QUALIFICATIONS

• MD or equivalent medical degree required.
• Board Certification in Medical Oncology, Hematology/Oncology, or a related specialty preferred.
• Minimum of 15 years of biotechnology or pharmaceutical industry experience, including at least 10 years in oncology clinical development.
• Demonstrated success leading global oncology clinical development programs.
• Extensive experience interacting with FDA and other global regulatory authorities.

PREFERRED QUALIFICATIONS

• Experience leading strategic partnerships or global development alliances.
• Experience developing biologics, antibody-drug conjugates, bispecific antibodies, or immuno-oncology therapies.
• Successful participation in global regulatory approvals and commercialization.

COMPETENCIES/CORE SKILLS

• Executive Leadership
• Oncology Clinical Development
• Strategic Partnership Management
• Scientific Leadership
• Global Regulatory Strategy
• Cross-Functional Collaboration
• Executive Communication
• Strategic Decision-Making
• Innovation
• Results Orientation

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.