Sr. Manager/Associate Director, Regulatory Program Management

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
 
Our business is inspired by our values:

• 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

We are seeking a Sr. Manager/Associate Director, Regulatory Program Management to support the Achondroplasia and related skeletal dysplasia regulatory team. This individual will partner closely with the Sr. Director, Program Management, SVP, Regulatory Affairs, and cross-functional team members to enable delivering on key regulatory and filing goals for the program. This position requires understanding of and experience in biotech/drug development, regulatory filings and project management for late-stage clinical programs. The ideal candidate will be developing leadership skills and will have exceptional attention to detail and organizational skills. The role requires someone who can organize projects effectively in a rapidly changing, fast-paced setting. We are looking for a self-starter that will help drive our achondroplasia program through to MAA and NDA filings and drive successful execution of our regulatory plans. Previous experience in a regulatory project management role within the pharmaceutical or biotech industry & experience with filings are a must.  

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate infigratinib, we seek to provide a treatment option to children living with Achondroplasia and their families. 

Responsibilities

• Work with the regulatory team to develop and maintain overall integrated project timelines across all regulatory deliverables, including NDA/MAA marketing application timelines
• Develop and maintain dashboards to identify and monitor critical items in preparation of global filings
• Develop and maintain timelines for pressure testing submission scenarios (i.e., base case, best case, and available data)
• Provide project management and logistical support for all agency interactions
• Proactively identify potential issues, constraints, bottlenecks, risks, gating items and mitigation management and escalates issues, as needed; propose solutions to support decision-making for the NDA/MAA
• Clearly and proactively communicate with leadership and program teams in a concise and timely manner: this can comprise written reports at desired cadence, visual aids/tracking systems to display progress and at-risk items for the NDA/MAA
• Assist team in scheduling regulatory cross functional meetings, capturing minutes, disseminating minutes and ensuring follow ups
• Ensure awareness, visibility and planning for regulatory submissions and effectiveness and efficiency in working towards ensuring timely submissions
• Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, risks for ACH and HCH
• Ensure review timelines are adequately managed across all key deliverables
• Update and maintain online documentation management systems
• Work within Veeva RIM to manage submission content plans, execute reports and dashboards, setup document development, and track health authority interactions  
• Provide a positive influence on the functioning of teammates and the team as a whole 

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

• Master’s degree in a scientific subject. PMP certification desirable
• 3+ years of experience in regulatory project management capacity with filing experience preferred
• 3+ years of hands-on project management experience at a fast-paced company is preferred
• Experience with Veeva RIM and eCTD formats and submission procedures for global filings preferred  
• Experience with timeline management tools (Smartsheet, MS Project, P6)
• Proactive and engaged
• Helpful, positive, team player mindset
• Critical thinking/problem solving and interpersonal communication skills
• Highly organized, meticulous attention to detail
• Ability to multi-task and handle pressures of a fast-paced environment  
• Demonstrated development of leadership skills, collaborating and influencing cross-functionally

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