Sr. Director/Executive Director, Clinical Development
Remote/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: Serve as overall clinical program owner for oligonucleotide therapeutic programs, driving them from IND submission through clinical proof-of-concept, pivotal studies, and regulatory engagement.

· Clinical strategy and development: Define and lead the clinical development strategy for programs targeting PNS and other relevant indications. Ensure the integration of translational insights, biomarker strategies, and regulatory considerations into cohesive clinical plans.

· Trial design and execution: Design and oversee early- and late-stage clinical trials (IIT, Phase 1–3) for siRNA therapeutics. Ensure clinical protocols are scientifically rigorous, operationally feasible, and aligned with regulatory and ethical standards.

· Translational integration: Partner with preclinical and translational biology teams to connect mechanistic and biomarker data with clinical endpoints. Translate preclinical findings into human studies to enable rational dose selection, patient stratification, and early efficacy assessment.

· Clinical operations leadership: Oversee cross-functional execution of clinical trials, ensuring alignment across clinical operations, biostatistics, regulatory, and CMC functions. Set milestones and drive data-driven decision-making to meet program timelines.

· Global site strategy: Guide site selection and operational planning across both U.S. and international locations. Ensure successful execution of trials in diverse geographies, maintaining compliance with global regulatory and ethical standards.

· Regulatory and medical affairs interface: Lead preparation and review of clinical sections of INDs, Investigator’s Brochures, and regulatory briefing documents. Represent clinical programs in regulatory interactions and advisory meetings.

· External collaboration: Build and manage productive relationships with CROs, investigators, and KOLs to strengthen program execution and strategic insight. Evaluate and manage academic and industry partnerships to advance clinical programs efficiently.

· Cross-functional leadership: Inspire and lead multidisciplinary teams, ensuring alignment and collaboration across R&D, clinical, and corporate functions. Foster a culture of transparency, scientific integrity, and urgency in execution.

Preferred Education & Experience

· M.D., M.D./Ph.D., or equivalent clinical degree in neurology, pharmacology, or related biomedical discipline.

· 10+ years of experience in clinical development, with at least 5 years in a senior leadership role.

· Proven success advancing oligonucleotide or other genetic medicine programs from IND through proof-of-concept and pivotal clinical studies.

· Deep expertise in clinical trial design, execution, and interpretation within peripheral nervous system (PNS) indications.

· Strong background in translational strategy, biomarker integration, and clinical pharmacology.

· Demonstrated ability to lead cross-functional clinical programs through regulatory interactions and global development.

· Regulatory-facing experience strongly preferred.

Nice-to-Haves

· Experience with siRNA or antisense oligonucleotide (ASO) therapeutic modalities.

· Prior involvement with international clinical sites.

· Familiarity with nucleic acid therapeutic delivery approaches and biomarkers for target engagement.

· Track record of building and scaling clinical development organizations in a fast-paced biotech environment.

· Experience interfacing with academic collaborators, CROs, and key opinion leaders in neurology and rare disease.

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 $336,000 to $380,000 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.