VP, Regulatory Affairs
Palo Alto, CA
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 regulatory affairs leader with deep expertise in early clinical development and a strong track record of delivering regulatory success for innovative therapies. You are comfortable setting strategy at the portfolio and program level while also rolling up your sleeves to get the work done in a small, fast‑moving biotech environment. You thrive at the intersection of science, clinical development, and regulatory execution, and you bring a pragmatic, solutions‑oriented mindset to navigating complex regulatory pathways, including those relevant to rare diseases and accelerated development.
Key?Responsibilities
Regulatory leadership & program ownership (pre-IND ? early PoC ? pivotal readiness): Serve as a regulatory leader for GondolaBio’s pipeline, defining stage‑appropriate global regulatory strategies, development paths, and decision gates from pre-IND through early proof of concept, with a focus on enabling rapid, high‑quality decisions
Early development regulatory strategy & execution: Develop and execute fit‑for‑purpose regulatory strategies to support first-in-human and early Phase 1/2 development across multiple modalities, balancing speed, rigor, and long‑term optionality, particularly in rare genetic diseases
Health authority interactions: Lead preparation for and conduct of regulatory interactions with FDA and international health authorities (e.g., EMA and other ex‑U.S. agencies), including briefing documents, meeting strategy, scientific advice, and written correspondence
INDs and regulatory submissions: Oversee and contribute directly to the planning, preparation, and submission of high‑quality INDs and amendments, ensuring strong integration across nonclinical, clinical, CMC, safety, and translational components, and a track record of successful outcomes
Accelerated and special pathways: Guide regulatory strategy for rare disease and accelerated development programs, including orphan designation, expedited pathways, and alignment on evidentiary standards appropriate for early proof of concept and downstream development
Global regulatory planning: Shape U.S. and ex‑U.S. regulatory strategies for early development, including CTA strategy, country sequencing, and alignment with international clinical and operational plans
External partner management & diligence: Manage external regulatory consultants and vendors as needed, and support regulatory diligence and partnering activities
Preferred Education & Experience
Advanced degree in a scientific discipline (Ph.D., Pharm.D., M.D., or equivalent)
15+ years of regulatory affairs experience in pharmaceutical or biotechnology settings, including leadership of regulatory strategy at the program or portfolio level
Demonstrated record of delivering regulatory success, including leading IND‑stage programs through key regulatory milestones and early clinical proof of concept
Experience with rare diseases and familiarity with accelerated or expedited regulatory pathways
Proven track record leading interactions with FDA and international health authorities, including briefing documents, meetings, and written responses
Strong understanding of early clinical development, translational biomarkers, and first‑in‑human safety considerations
Experience operating in small or mid‑sized biotech environments where leaders are both strategic and hands‑on
Nice-to-Haves
Familiarity with multiple therapeutic modalities, including oligonucleotides and small molecules
Prior experience serving as the primary regulatory voice with executive leadership, boards, or investment committees
Comfort advising on regulatory risk in the context of business decisions, including asset prioritization, timelines, and capital allocation
Willingness and ability to operate with limited precedent and incomplete data while maintaining regulatory credibility
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 is $288,000 to $365,000 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.
#J-18808-Ljbffr