With a singular focus, QED, s subsidiary of BridgeBio Pharma, is devoted to the development of our investigational candidate, infigratinib. A first-in-class, selective, tyrosine kinase inhibitor, infigratinib has promising early clinical data in patients with previously treated, FGFR-driven cholangiocarcinoma and metastatic urothelial carcinoma, as well as preclinical studies in achondroplasia. Future studies will investigate infigratinib for additional FGFR-driven tumor types and rare disorders.
FGFR=fibroblast growth factor receptor.
BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country.
Who You Are
This is an exciting opportunity for a Clinical Pharmacology Scientist 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. The 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.
- Participate in the design of clinical pharmacology strategy 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
Education, Experience & Skills Requirements
- A PharmD or Ph.D. with 1+ 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 enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
- Learning and development training to help employees be the best version of themselves
- Collaborative business environment
- Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
- Excellent benefits package
- Flexible PTO
- With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
- A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
- Work with the most productive groups of R&D operators in the industry
- Partnerships with leading institutions
- A platform for meaningful scientific contributions to shine
- Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so