Director / Senior Director of Clinical Pharmacology

Location
Palo Alto, CA, United States
Posted
Nov 19, 2020
Ref
1028659809
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
With singular focus, QED Therapeutics, a 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.

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 aim 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.

To learn more, visit us at https://www.qedtx.com/ | https://bridgebio.com

Location:

Brisbane, CA

Who You Are:

This position is responsible for efficient, innovative, clinical pharmacology, PK/PD, and/or population PK study design, analysis, interpretation, and reporting to support international regulatory submissions. You will interact with multidisciplinary groups across the company including clinical development, biostatistics, clinical operations, regulatory, non-clinical, quality and business development.

Responsibilities:
  • Assisting in participating in design of the clinical pharmacology component of drug development programs consistent with company and R&D program goals
  • Clinical study protocol design, data analysis/interpretation, and reporting of studies by preparing CSRs and various regulatory documents (INDs, NDA's, IB's, etc.)
  • Determining scope, design, planning and analysis of phase 1-4 pharmacokinetic and pharmacodynamics studies, including developing appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization
  • Planning, preparing and reviewing drug development plans and regulatory filings
  • Identifying and managing consultants and vendors supporting clinical pharmacology studies
  • Able to address FDA/EMA regulatory questions from IND, protocols and NDA filings
  • Effective participation on cross functional teams representing early development department to insure integration of modern pharmacology principles into project plans
  • Work closely with Bioanalytical vendors, Project Managers, Clinical Researchers, Biostatisticians and Clinical Trials Managers to support clinical development programs

Qualifications:
  • PhD or PharmD with 7+years of experience with clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysis in the pharmaceutical/Biotech industry
  • Small molecule development experience
  • Strong understanding of clinical pharmacology principles and the drug development process
  • Good working knowledge of Phoenix and other PK/PD software
  • Ability to work both independently and on strong cross functional teams
  • Demonstrated superior oral and written presentation skills required
  • Collaborative and flexible in personal interactions at all levels of the company

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