Director, DMPK | BridgeBio Pharma | Remote (US)

Director, DMPK | BridgeBio Pharma | Remote (US)

Remote US
Application ends: September 19, 2024
Apply Now

Job Description

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

This is an exciting opportunity for a highly motivated and experienced DMPK leader to design and execute DMPK strategies to support clinical development programs, including the study design, protocol review, overseeing study execution, data analyses, and reporting. This successful candidate will be a member of cross-functional teams, ensuring that DMPK strategies are appropriately considered and executed timely to support marketing applications. This position can be remote.

Responsibilities

  • Serve as DMPK/BA lead for both early and late-stage pediatric clinical development programs
  • Develop and implement DMPK strategies to support NDA/MAA submissions
  • Design, execute and troubleshoot in vitro and in vivo ADME, DMPK, PK/PD studies with CRO to investigate complex mechanistic ADME for small molecule drugs
  • Analyze, interpret, report DMPK study data, and present DMPK study results internally to project teams and externally to stakeholders/collaborators and in
  • Author, review and edit relevant sections of regulatory submissions including modules 2.6.4 and 2.6.5 for NDA/MAA and respond to queries from regulatory agencies
  • Manage vendors and contracts

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

  • Ph.D. in Pharmaceutical Sciences, or related discipline with a focus on drug metabolism and pharmacokinetics. At least 8 years’ industry experience in DMPK/BA focused on small molecules. Equivalent experience may be accepted
  • In depth knowledge of DMPK and PK/PD concepts and relevant areas such as physicochemical properties, drug metabolizing enzyme and transporter kinetics, pharmacokinetics, biotransformation and bioanalytical sciences
  • Demonstrated experience and track record in designing and overseeing DMPK studies, experience with pediatric programs is preferred
  • Experience with PBPK and PK/PD modeling and extrapolation to pediatric population including infant and toddler is desirable
  • Knowledgeable in the FDA and EMA regulatory guidance, requirements, and expectations
  • Ability to work effectively in a dynamic, fast-paced, collaborative, and team-oriented environment. Demonstrate critical thinking and problem-solving capabilities
  • Excellent interpersonal, verbal, and written communication skills to communicate effectively with external collaborators and internal project teams

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