Senior Vice President OF Regulatory Affairs

Fully Remote • Remote with travel to Bay Area

Description

About GondolaBio

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting‑edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

Who You Are

You are an experienced toxicologist with deep expertise in oligonucleotide therapeutics. You bring strong scientific judgment and a track record of designing, executing, and interpreting nonclinical safety programs that support regulatory submissions and clinical development.

You are hands‑on, rigorous, and comfortable working through programs at high speed and navigating through complex or unexpected toxicology findings. You integrate toxicology, toxicokinetics, pharmacology, biodistribution, histopathology, and clinical context to assess human relevance and guide program decisions. You work effectively across Research, DMPK, Clinical, Regulatory, and CMC and thrive in a lean environment that relies heavily on CROs, consultants, and external partners.

Above all, you maintain scientific integrity and keep patient safety at the center of every decision.

Key Responsibilities

Provide scientific and operational leadership for nonclinical safety programs from candidate selection through clinical development, including:

Toxicology Strategy and Study Design

• Develop integrated nonclinical safety strategies for oligonucleotide therapeutic programs.
• Design and oversee exploratory, IND‑enabling, and clinical‑supporting toxicology studies, including general toxicology, safety pharmacology, genotoxicity, reproductive toxicology, and other specialized studies as appropriate.
• Recommend relevant species, dose levels, dosing routes, dosing intervals, recovery periods, and safety‑monitoring parameters based on pharmacology, exposure, tissue distribution, and anticipated clinical use.
• Establish appropriate safety margins and translate nonclinical findings into clinical dose‑selection and risk‑mitigation strategies.
• Oligonucleotide Safety Assessment
• Lead the evaluation of toxicities associated with oligos, conjugates, delivery technologies, and their metabolites.
• Assess potential class‑related and platform‑related findings, including effects involving the liver, kidney, platelets, coagulation, immune activation, complement, injection or infusion reactions, and other relevant organ systems.
• Integrate toxicology, toxicokinetics, biodistribution, pharmacology, bioanalytical, clinical pathology, and histopathology data to determine mechanism, dose dependence, reversibility, species relevance, and potential human risk.
• Lead investigations of unexpected findings and develop scientifically rigorous follow‑up strategies.

Study Execution and CRO Oversight

• Select, manage, and provide scientific oversight of CROs, consultants, pathologists, and other external partners.
• Review and approve study designs, protocols, amendments, data, pathology findings, and final reports.
• Ensure studies are conducted with appropriate scientific rigor, quality standards, timelines, and regulatory compliance.
• Monitor study progress closely, identify emerging risks, and drive timely resolution of scientific and operational issues.

Regulatory and Clinical Support

• Author and review toxicology sections of regulatory submissions, including pre‑IND briefing packages, INDs, investigator brochures, annual reports, and responses to regulatory questions.
• Represent toxicology in interactions with global regulatory authorities and external experts.
• Translate nonclinical findings into practical clinical monitoring, stopping rules, dose‑escalation criteria, and risk‑management plans.
• Provide toxicology support throughout clinical development, including assessment of emerging clinical safety findings and their relationship to the nonclinical data.

Cross‑Functional Leadership

• Partner closely with Research, DMPK, Clinical Development, Regulatory Affairs, CMC, Bioanalytics, and Quality to deliver integrated development plans.
• Communicate complex toxicology findings clearly to program teams, senior leadership, boards, investigators, and external advisors.
• Contribute to candidate selection, portfolio prioritization, due diligence, and program investment decisions.
• Build toxicology capabilities, processes, and external networks appropriate for a lean, rapidly growing organization.

Requirements

Preferred Education & Experience

• PhD, DVM, MD, or equivalent advanced degree in toxicology, pharmacology, pathology, or a related scientific discipline.
• Minimum of 10 years of relevant biopharmaceutical toxicology experience, including experience leading nonclinical safety programs.
• Direct experience developing oligonucleotide therapeutics is required.
• Demonstrated experience designing and interpreting exploratory and GLP toxicology studies supporting INDs or equivalent global regulatory submissions.
• Strong understanding of oligonucleotide‑related toxicities, toxicokinetics, tissue distribution, immunotoxicology, clinical pathology, and histopathology.
• Experience advancing programs from candidate selection into clinical development.
• Experience investigating complex or unexpected toxicology findings and assessing their relevance to humans.
• Experience managing CROs, consultants, and external pathology and toxicology partners.
• Strong record of cross‑functional collaboration with Research, DMPK, Clinical Development, Regulatory Affairs, and CMC.
• Excellent scientific writing, communication, and presentation skills.
• Thrives in a hands‑on, detail‑oriented role and is energized by directly driving work forward in a fast‑moving environment.

Nice‑to‑Haves

• Board certification in toxicology, such as DABT, or veterinary pathology, such as DACVP
• Experience with lipid-, peptide-, antibody-, or GalNAc‑conjugated oligonucleotides.
• Experience with intravenous and subcutaneous oligonucleotide development programs.
• Experience supporting rare or genetic disease programs.
• Experience interacting directly with the FDA and other global regulatory authorities.

No matter your role at GondolaBio, successful team members are

• Patient Champions, who put patients first and uphold strict ethical standards.
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset.
• Truth Seekers, who are detailed, rational, and humble problem solvers.
• Individuals Who Inspire Excellence in themselves and those around them.
• High‑quality executors, who execute against goals and milestones with quality, precision, and speed.

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts.
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
• An unyielding commitment to always putting patients first.
• A de‑centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision‑making power in the hands of those closest to the science.
• A place where you own the vision – both for your program and your own career path.
• A collaborative, fast‑paced, data‑driven environment where we inspire ourselves and each other to always perform at the top of our game.
• Access to learning and development resources to help you get in the best professional shape of your life.
• Robust and market‑competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs).
• Flexible PTO.
• Rapid career advancement for strong performers.
• Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time.
• Partnerships with leading institutions.
• Commitment to Diversity, Equity & Inclusion.

The base pay range for this position for the United States is $275,000 to $350,000 per year. The actual compensation offered will be determined based on a number of job‑related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.

GondolaBio ServiceCo is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Employees of BridgeBio and all affiliated companies should work through their managers to inquire about and learn more about this role.