Senior Scientist Clinical Pharmacology

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, TRUSELTIQTM (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 Scientist/Senior Scientist, Clinical Pharmacology to provide clinical pharmacology and DMPK support to all clinical development programs, including the study design, protocol review, clinical study conduct, PK and PD data analyses, and reporting of the studies.  This successful candidate will be a member of cross-functional teams, ensuring that clinical pharmacology aspects are appropriately considered in the development and execution of all clinical studies to advance safe and efficacious therapies to patients. This position will report to the VP of Clinical Pharmacology and will be remote.

Responsibilities:

• Participate in the design of clinical pharmacology strategies and studies to support clinical development programs and inform appropriate dosing decisions for patients
• Contribute to and review clinical study protocols, study analysis plans, and reports
• Conduct hands-on non-clinical and clinical data analysis, including non-compartmental analyses and PK/PD modeling. Manage population PK/PD modeling and exposure-response (efficacy and safety) analyses based on evolving data to advance clinical programs.
• Collaborate with the clinical operation, clinical development, data management, and biostatistics, and cross-functional project teams in vendor selection and clinical study execution. Oversee the proper collection, processing, and testing of PK and biomarker samples.
• Author clinical pharmacology sections of clinical study reports, present PK/PD data at cross-functional team meetings
• Present the study results externally in meeting abstracts, posters, and/or manuscripts in scientific journals.
• Author clinical pharmacology and DMPK sections of documents for regulatory submissions
• Manage external clinical pharmacology vendors
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 at least 2+ years, an MS with 4+ years of experience in clinical pharmacology in the biotech/pharmaceutical industry; Equivalent experience may be accepted
• Must have hands-on experience with clinical pharmacology and ADME study design, data analysis, non-compartmental and PK/PD modeling using data processing software such as Phoenix WinNonlin and R
• Familiar with quantitative approaches in drug development. Working knowledge of relevant modeling software such as NONMEM, MONOLIX, Berkeley Madonna, or SimCyp is desirable. Proficiency in statistical and graphing software such as SigmaPlot, Prism, JMP, or R
• In-depth understanding of PK/PD, drug metabolism, translational pharmacology, and drug development concepts
• Ability to work effectively in a dynamic, fast-paced, collaborative, and team-oriented environment. Demonstrate critical thinking and problem-solving capabilities
• Good project management skills and the ability to manage multiple, diverse tasks and to prioritize tasks effectively is required
• Attention to details, able to proactively identify issues and propose solutions
• Excellent written and verbal communication and interpersonal skills, initiative, and commitment to excellence are required; must be able to independently create high-quality written reports and summary documents for use in regulatory submissions
• Knowledge in regulatory guidance, requirements, and expectations in the US and internationally, and ICH and GCP 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 – 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.