VP, Clinical Development
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 clinical development leader with deep expertise in peripheral nervous system (PNS) disorders and a proven record of success in designing and executing oligonucleotide-based clinical trials (siRNA, ASO). You thrive in dynamic, cross-functional settings and are driven by translating scientific breakthroughs into meaningful patient outcomes. You combine strategic clinical insight with operational discipline and inspire multidisciplinary teams to deliver high-quality, data-driven results.
Key?Responsibilities
· Program ownership (FIH ? PoC ? pivotal readiness): Serve as overall clinical owner for some of our oligo therapeutics through early clinical PoC; define stage-appropriate target engagement, endpoints, and Go/No-Go gates.
· FIH/early development design & delivery: Establish fit-for-purpose clinical endpoints and a clear regulatory path (from IND through early PoC), then architect and execute SAD/MAD/FIH and Phase 1/2 studies—across company-sponsored and investigator-initiated (IIT) settings
· Neuromuscular/PNS & genetic-disease endpoints: Select and operationalize relevant functional, electrophysiologic, and biomarker endpoints (e.g., strength/function, nerve conduction/electrophysiology, patient-reported outcomes, digital measures) with fit-for-purpose statistical and sampling plans.
· Oligonucleotide clinical pharmacology: Integrate modality-specific considerations (e.g., tissue exposure, PD biomarkers/target engagement, dosing interval, immunostimulation risk) into protocol design, bioanalytical strategy, and modeling/simulation.
· Translational integration: Convert preclinical/biomarker learnings into clinical hypotheses,
· External network & site strategy: Develop KOL and site networks in neuromuscular/PNS and rare genetic disease centers; shape U.S./ex-U.S. site footprint, feasibility, and country mix.
· Cross-functional leadership: Align Clinical Ops, Stats, PK/PD, Regulatory, Safety, CMC, and Finance on clear decision frameworks; communicate crisp program status to leadership.
Preferred Education & Experience
· M.D., M.D./Ph.D., or equivalent clinical degree (neurology or related discipline preferred).
· 15+ years in clinical development with 5+ years in senior leadership driving programs through FIH/early development; biotech experience strongly preferred.
· Demonstrated success advancing oligonucleotide or other genetic-medicine programs from IND through early PoC (pivotal readiness a plus).
· Deep experience with neuromuscular/PNS and/or genetic-disease clinical endpoints and outcome measures, including biomarker integration.
· Proven ownership of company-sponsored interventional trials (and productive collaboration on IITs), including CRO/vendor governance and budget accountability.
· Hands-on clinical pharmacology/PK-PD mindset for early development and dose selection.
· Regulatory-facing leadership (pre-IND/IND meetings, written responses, safety updates).
Nice-to-Haves
· Experience with ASO/siRNA delivery, target-engagement biomarkers, and digital/remote assessments in neuromuscular populations.
· Global trial execution across rare-disease centers; start-up in complex geographies.
· Track record building/scaling lean clinical organizations and mentoring high-performing teams.
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 $380,000 to $405,000 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.