Medical Director, Clinical Development

About QED Therapeutics & BridgeBio Pharma

• PUT PATIENTS FIRST
• LET SCIENCE SPEAK
• EVERY MINUTE COUNTS
• THINK INDEPENDENTLY
• BE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

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 30+ 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 aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

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

Who You Are

As a Medical Director, 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 Achondroplasia program and will be the medical monitor for clinical studies, contributing scientific knowledge and expertise.

Responsibilities

• Provide expert support for the preparation of clinical protocols and protocol amendments
• Responsible for the clinical sections of regulatory documents (IB, IND, DSUR, etc.)
• Work with team members to prepare publications and presentations for external meetings
•  Function as the clinical representative on cross-functional and project teams meetings
• Serve as medical monitor for achondroplasia 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
• 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
• May travel 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 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

Education, Experience & Skills Requirements

• Trained MD and/or MD-Ph.D. degree
• 5+ years of experience in drug development, either within the industry or as a clinical investigator/physician-scientist in academia, or equivalent experience.
• Experience in rare disease fields or/and pediatric endocrinology is a plus
• Good understanding of the drug development process, protocol writing, and study conduct
• Good knowledge of GCP
• Strong interpersonal and leadership skills
• Ability to work independently in a fast-paced environment
• Excellent written and verbal communication skills

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