Director/Senior Director, DMPK

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Navire Pharma, a subsidiary of BridgeBio Pharma, is a clinical stage biopharmaceutical company focused on harnessing breakthrough discoveries in our understanding of SHP2 to address the large and growing unmet need in rare and difficult-to-treat cancers. Navire’s team of veteran biotechnology executives are partnering with leading cancer experts to advance effective therapies to patients as rapidly as possible.

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. 

To learn more, visit us at https://navirepharma.com/https://bridgebio.com

Location

Remote

Who you are:

Navire seeks an experienced DMPK leader to guide clinical and non-clinical pharmacokinetics and pharmacology. This Director/Sr. Director of DMPK will lead study design, implementation, and interpretation to drive drug candidate optimization and progress in the clinic. This person will establish DMPK strategy, tactical planning with internal research teams and external CROs, overseeing execution, monitoring, and reporting while ensuring high-data quality for regulatory submissions. This position reports to the Vice President of DMPK.

Responsibilities

  • Serve as DMPK subject matter expert on cross-functional teams in both early and late-stage projects
  • Define ADME strategy to achieve target product profile
  • Design and outsource in vitro and in vivo ADME studies to characterize the compound
  • Design and perform complex PK analysis, model development, and PK/PD analyses
  • Interprets and presents DMPK scientific data/results to the team
  • Assists in clinical study protocol design, data analysis/interpretation, and reporting
  • Write, review and edit relevant sections of regulatory submissions – IND, DSUR, NDA, etc., and respond to queries from regulatory agencies

Education, Experience & Skills Requirements

  • Ph.D. in Pharmaceutical Sciences, or related discipline with a focus on pharmacokinetics, ADME, and PK/PD modeling and simulation
  • At least 10 years’ experience in PK study design, PK analysis, population PK analysis, PK/PD and PBPK modeling, human dose prediction, and report writing
  • Strong background in bioanalysis  
  • Working knowledge of regulatory guidance for PK analysis and clinical pharmacology
  • Ability to collaborate and effectively lead cross-functionally and in a team setting
  • Excellent interpersonal and written communication skills to communicate effectively with external collaborators and internal project teams

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
careers

Director/Senior Director, DMPK

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