Who You Are

You are a translational medicine leader operating at the interface of discovery and early clinical development, with deep expertise in biomarker strategy, assay development, and clinical implementation. You have a proven track record of translating preclinical insights into clinically deployable biomarker strategies and executing these strategies in global clinical studies.
 

You bring a strong scientific foundation in biomarker biology and assay technologies, experience working within CLIA-certified or regulated laboratory environments, and the ability to operate cross-functionally across discovery, clinical development, and clinical operations. You are execution-oriented, capable of driving work through CROs and external partners, and thrive in a fast-paced biotech environment. Experience in neurology or CNS disorders is preferred but not required.

Role Overview

This role will lead clinical biomarker strategy and execution across GondolaBio’s early neuroscience clinical programs. The individual will be responsible for translating discovery-stage hypotheses into clinically actionable biomarker approaches, ensuring assays are fit-for-purpose, validated, and operationally feasible in global studies. This role will directly impact how target engagement, pharmacodynamic effects, and disease biology are measured in patients.

Key Responsibilities

• Partner with discovery and preclinical teams to identify and prioritize translational biomarkers
• Translate preclinical findings into clinical biomarker strategies, including pharmacodynamic, target engagement, and disease-relevant endpoints
• Lead development, qualification, and validation of biomarker assays
• Oversee assay transfer, validation, and execution at CROs and external laboratories
• Ensure assays are implemented in CLIA-compliant or equivalent environments when appropriate
• Partner with Clinical Operations to design sample collection schedules, lab manuals, and logistics workflows
• Coordinate with clinical sites and vendors to ensure sample integrity and operational feasibility
• Integrate biomarker data with clinical, PK/PD, and safety datasets to generate decision-ready insights
• Contribute to clinical protocol design, regulatory documentation, and cross-functional decision-making
• Serve as a key partner across discovery, clinical development, clinical operations, regulatory, and data science teams

Preferred Education & Experience

• PhD, MD, or equivalent in a relevant discipline
• 10–15+ years of experience in translational medicine, biomarker sciences, or clinical bioanalysis
• Experience supporting early clinical development (pre-IND through Phase 1/2)
• Experience managing biomarker strategies in global clinical studies and working with CROs
• Strong understanding of biomarker assay platforms and bioanalytical validation principles
• Experience working in or with CLIA or regulated laboratory environments

Nice-to-Haves

• Experience in neurology or CNS disorders
• Experience with intrathecal or CNS-targeted therapeutics
• Familiarity with CSF biomarker workflows or neurophysiological biomarkers (e.g., EEG)
• Experience contributing to regulatory submissions

No Matter Your Role at GondolaBio, Successful Team Members Are 

• Patient Champions who put patients first, uphold strict ethical standards, and anchor decisions in clinical and scientific integrity. 
• Entrepreneurial Operators who take ownership and drive toward practical solutions, while exercising sound judgment, respecting established processes, and aligning with teammates and leadership. 
• Truth Seekers who are rigorous, detail-oriented, and intellectually honest—comfortable challenging assumptions, engaging with data, and updating their views based on evidence. 
• Collaborative Thinkers who work effectively in data-driven, interdisciplinary environments; listen actively; and welcome questions, debate, and constructive challenge as essential to better decision-making. 
• Individuals Who Inspire Excellence in themselves and those around them. High-quality Executors who deliver against goals and milestones with precision, accountability, and appropriate urgency—without compromising scientific rigor or team alignment. 

What We Offer 

GondolaBio offers a collaborative, fast-paced, and data-driven environment that emphasizes patient impact, scientific rigor, and ownership. Additionally, 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