Associate Director, Clinical Pharmacology

Full-TimeQEDAny Office LocationPreclinical / Clinical Pharmacology

Apply Now

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on precision medicine for FGFR-driven cancers and diseases. The company’s first therapy, TRUSELTIQ (infigratinib), is an orally administered FGFR1-3 tyrosine kinase inhibitor that the US FDA recently approved to treat patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. We are also evaluating infigratinib for the treatment of other FGFR-driven cancers and the treatment of achondroplasia and other skeletal dysplasias.

QED is derived from the Latin “Quod Erat Demonstrandum” —Thus; It Has Been Proven. 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, Boston, New York, and Raleigh, 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 clinical pharmacologist to support global clinical development programs. The successful candidate will oversee clinical pharmacology studies and be the clinical pharmacology lead in cross-functional teams, ensuring that clinical pharmacology aspects are appropriately considered in the development and execution of all clinical studies. This position will report to the VP of Clinical Pharmacology.
Responsibilities:
  • Responsible for the development and implementation of clinical pharmacology study and quantitative analysis plans to support global clinical development programs and inform appropriate dosing decisions for the right patient population
  • Represent clinical pharmacology function in study teams and build strong working relationships with cross-functional teams to ensure high-quality study execution
  • Conduct clinical data analysis, including non-compartmental analyses, population PK, and PK/PD modeling based on evolving data to advance clinical programs. Able to interpret PK and PK/PD data and integrate this knowledge into optimizing clinical trials and the overall clinical program
  • Use quantitative approaches to address questions arising during drug development (including dose selection, clinical trial design, unique population dosing, benefit/risk assessment)
  • Oversee the proper collection, processing, and testing of PK samples
  • Author clinical pharmacology sections of the clinical study protocol and study reports, and regulatory filings such as IB, EOP2, briefing books for meetings with the FDA/EMA/PMDA
  • Present study results internally to project teams and externally in the forms of meeting abstracts, posters, and/or manuscripts in scientific journals
  • Manage consultants/vendors to conduct clinical pharmacology studies

  • 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 towards 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:
  • A PharmD or Ph.D. with 5+ years of experience in clinical pharmacology in the biotech/pharmaceutical industry. Equivalent experience may be accepted
  • Demonstrated experience and track record in the running and/or overseeing clinical pharmacology studies
  • In-depth knowledge of PK data analysis and interpretation, drug metabolism, translational pharmacology; track record in applying these concepts to support clinical development programs
  • Expertise in quantitative approaches in drug development with experience in relevant software such as NONMEM, MONOLIX, or R
  • Ability to work effectively in a dynamic, fast-paced, collaborative, and team-oriented environment. Demonstrate critical thinking and problem-solving capabilities
  • Excellent written and verbal communication and interpersonal skills
  • Knowledgeable in the FDA and EMA regulatory guidance, requirements, and expectations
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 – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Associate Director, Clinical Pharmacology

Full-TimeQEDAny Office LocationPreclinical / Clinical Pharmacology

Apply Now