Senior Medical Director / Vp, Clinical Development Palo Alto, California, United States

GondolaBio is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for genetic diseases. Originally launched as BridgeBioX, a subsidiary of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. The company aims to leverage cutting-edge biological research to create breakthrough medicines addressing high unmet needs across multiple therapeutic areas, including neurology, pulmonology, cardiology, nephrology, and endocrinology. Located on the Stanford Life Sciences campus, GondolaBio fosters a unique hybrid environment where top scientists from around the world collaborate with senior leadership and advisors, blending industry expertise with academic innovation.
About BridgeBioBridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
As a Senior Medical Director/VP of Clinical Development, this candidate will play an essential role in the planning, implementation, and daily operation of drug development program(s). This person will collaborate with key internal and external stakeholders to support the Erythropoietic Protoporphyria program and will be the medical monitor for clinical studies, contributing scientific knowledge and expertise.
ResponsibilitiesLead clinical study teams and partner with investigators and CROs to design and implement clinical studies (Phase 1 through Phase 3)Serve as medical monitor for clinical studies, responsible for safety monitoring of clinical trials, and as a medical expert for Phase I-III studies, managing the process from protocol development through the study execution to completion of study reports and integrated regulatory documentsContribute to and oversee the writing of clinical study protocols, investigator brochures, and clinical study reports, and review clinical trial documentsConduct investigator meetings and safety review committee meetings and lead site initiation visits with clinical trial investigatorsExecute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgetsTranslate findings from research and nonclinical studies into actionable clinical development opportunitiesInteract with clinical investigators and thought leadersAssist with writing and preparation of abstracts, presentations, and manuscriptsRemain current in relevant therapeutic areas and conversant with the literature as well as critical emerging dataRepresent the Clinical Development team during interactions with regulatory agencies, as applicableCollaborate with cross-functional colleagues (clinical operations, statistics, regulatory affairs, CMC team, medical affairs, etc.)Cultivate relationships with investigative sites, clinical consultants, and key opinion leadersParticipate in and lead Clinical Advisory BoardsHelp ensure Clinical Study Team compliance with FDA, EMEA, ICH, and GCP guidelines and internal SOPsTravel up to 20% domestically and internationally for scientific meetings, Advisory Boards, etc.No matter your role at BridgeBio, successful team members are: Patient Champions, who put patients first and uphold strict ethical standardsEntrepreneurial Operators, who drive toward practical solutions and have an ownership mindsetTruth Seekers, who are detailed, rational, and humble problem solversIndividuals Who Inspire Excellence in themselves and those around themHigh-quality executors, who execute against goals and milestones with quality, precision, and speedEducation, Experience & Skills RequirementsTrained MD or MD-Ph.D. degree5-10 (or more) years of experience in drug development, either within the industry or as a clinical investigator/physician-scientist in academia or equivalent experiencePatient-focused, with a deep commitment to understanding needs and improving the lives of patients, and a passion for developing novel therapeuticsDemonstrated ability to collaborate successfully with multiple functions in a team environmentDemonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detailMotivated to work in a fast-paced, high accountability, small company environment; a "can do" and collegial professional who leads through influence and interpersonal skillsOwnership mindsetIntellectually curious with the courage to challenge and seek new ways to improve workStrong written and oral communication skills, including presentation skillsAbility to analyze and interpret data and develop written reports and presentations of those dataSolid critical, strategic, and analytical thinking skillsExperience in all aspects of protocol conduct, both early and late phases, including protocol writing, start-up, study execution, analysis, and reportingExperience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trialsExperience in rare disease fields and/or dermatology, hepatology, or non-malignant hematology is a plusWhat We OfferPatient Days, where we hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our effortsA culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speakA 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 scienceA place where you own the vision – both for your program and your own career pathA collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our gameAccess to learning and development resources to help you get in the best professional shape of your lifeRobust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)Flexible PTORapid career advancement for strong performersPotential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over timeCommitment to Diversity, Equity & InclusionAt GondolaBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. GondolaBio is a multi-state employer, and this salary range may not reflect positions based in other states.

#J-18808-Ljbffr