What are the responsibilities and job description for the Director/Sr. Director, Clinical Development position at GondolaBio LLC?

Job Description

Description : About GondolaBio

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 BridgeBio

BridgeBio 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.

Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https : / / bridgebio.com

Who You Are

As a Director / Sr. Director 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.

Requirements : Responsibilities

Lead 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 documents
Contribute to and oversee the writing of clinical study protocols, investigator brochures, and clinical study reports, and review clinical trial documents
Conduct investigator meetings and safety review committee meetings and lead site initiation visits with clinical trial investigators
Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
Translate findings from research and nonclinical studies into actionable clinical development opportunities
Interact with clinical investigators and thought leaders
Assistance with writing and preparation of abstracts, presentations, and manuscripts
Remain current in relevant therapeutic areas and conversant with the literature as well as critical emerging data

No matter your role at BridgeBio, 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

Represent the Clinical Development team during interactions with regulatory agencies, as applicable

Collaborate with (and serve as a clinical / medical resource) for cross-functional colleagues (clinical operations, statistics, regulatory affairs, CMC team, medical affairs, etc.)

Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders

Participate in and lead Clinical Advisory Boards

Help ensure Clinical Study Team compliance with FDA, EMEA, ICH, and GCP guidelines and internal SOPs

Travel up to 20% domestically and internationally for scientific meetings, Advisory Boards, etc.

Education, Experience & Skills Requirements

Trained MD or MD-Ph.D. degree

5-10 (or more) years of experience in drug development, either within the industry or as a clinical investigator / physician -scientist in academia or equivalent experience

Patient-focused, with a deep commitment to understanding needs and improving the lives of patients, and a passion for developing novel therapeutics

Demonstrated ability to collaborate successfully with multiple functions in a team environment

Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail

Motivated to work in a fast-paced, high accountability, small company environment; a "can do" and collegial professional who leads through influence and interpersonal skills

Ownership mindset

Intellectually curious with the courage to challenge and seek new ways to improve work

Strong written and oral communication skills, including presentation skills

Ability to analyze and interpret data and develop written reports and presentations of those data

Solid critical, strategic, and analytical thinking skills

Experience in all aspects of protocol conduct, both early and late phases, including protocol writing, start-up, study execution, analysis, and reporting

Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trials

Experience in rare disease fields and / or dermatology, hepatology, or non-malignant hematology is a plus

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. Learn more about how we do this here

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 BridgeBio Pharma programs across multiple therapeutic areas over time

Partnerships with leading institutions

Commitment to Diversity, Equity & Inclusion

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Director/Sr. Director, Clinical Development

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