Vice President, Global Drug Safety Lead

ABOUT THE COMPANY

Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next-generation biologics from concept to clinic. At Fortvita, you’ll have the opportunity to make a meaningful impact on patients’ lives worldwide while working in a collaborative, mission-driven environment.

POSITION SUMMARY

We are seeking an accomplished Global Safety Drug Lead to join our team, this role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned products throughout life cycle. This pivotal role necessitates close collaboration with cross-functional teams, including Clinical Development, Regulatory Affairs, and other departments to foster and uphold a robust drug safety culture.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Responsible for implementing risk management strategies for assigned products.
• Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses.
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents.
• Supervise and ensure timely submission of periodic and ad hoc safety reports to global regulatory authorities, including PBRERs/PSURs, DSURs, and safety components of IND/NDA/MAA filings.
• Effectively collaborate with drug safety and cross-functional teams for safety assessment (e.g. review of AEs; safety reports; trial protocols; clinical study reports), ongoing surveillance, and related communication around assigned products.
• Design and execute drug safety training programs to enhance awareness and response capabilities among internal and external stakeholders.
• Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management.
• Foster strong relationships with KOLs, external experts, and industry associations, staying abreast of industry trends, and participating in global collaborative projects.

REQUIRED QUALIFICATIONS

• MD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
• Minimum requirement: 10 years’ experience in in drug safety/pharmacovigilance physician in clinical development.
• Experience in pharmaceutical or biotech industry working with Phase I – III clinical trials, experience in Oncology.
• Oncology experience and clinical development experience are strongly preferred.
• Experience with global PV regulatory environment (regulations, initiatives, standards, GVP)
• 7 years of leadership experience, including building and leading teams
• Travel up to 20%

COMPETENCIES/CORE SKILLS

• Work collaboratively and lead cross-functional teams.
• Good interpersonal and ownership.
• 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

BENEFITS

• Competitive base salary, bonus, and equity for all employees
• 401(k) retirement plan with employer matching contributions
• Comprehensive medical, dental, and vision insurance
• Generous paid time off policy, including company holidays and floating holidays

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.