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Sr. Scientist, Clinical Pharmacology

At Blueprint Medicines, as our name indicates, we are creating a blueprint for the future of healthcare.  We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease.  We do this by leveraging our one-of-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally.  This prolific scientific platform has enabled Blueprint Medicine to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.

Blueprint Medicines is seeking an experienced Clinical Pharmacologist. This position reports into the Director of Clinical Pharmacology and will be responsible for providing strategic and operational clinical pharmacology and pharmacokinetics support to project teams. The right candidate will possess a working knowledge of clinical pharmacology and have experience designing, analyzing and reporting clinical pharmacology study results.

Responsibilities

  • Provide strategic clinical pharmacology guidance to cross functional project teams
  • Develop clinical pharmacology plans (e.g. assessment of QT, food effect, ADME, DDI strategy, special populations, etc.) to support development and fast registration of Blueprint products.
  • Responsible for planning, design and execution of clinical pharmacology studies, work cross-functionally to establish clinical protocols, oversee clinical study conduct collaborating with Clinical Operations, data review, analysis, and reporting.
  • Monitor work with CRO’s/external vendors to ensure compliance with agreed protocols, quality standards and timelines.  Review external data. 
  • Lead the analysis, interpretation and reporting of clinical pharmacokinetic data
  • Manage bioanalysis, PK, and metabolite profiling activities at CROs/external vendors
  • Co-author regulatory submission documents (CTD, Investigator brochure (IB), EOP2 meetings, NDA)

Qualifications

  • PhD or PharmD in Clinical Pharmacology, Pharmacokinetics or a related field with 3+ years of bio/pharmaceutical industry experience as a clinical pharmacologist.
  • Knowledge of pharmacokinetics and modeling, PK/PD principles, ADME concepts, and regulatory clinical pharmacology requirements to support clinical development
  • Demonstrated ability to manage the clinical pharmacology/pharmacokinetic components of projects
  • Proficient in using Phoenix WinNonlin

Capabilities

  • Ability to work effectively and collaboratively on cross functional project teams, in a fast-paced, dynamic environment under tight timelines
  • Excellent project management and people skills
  • A team player, effective listener, clear communicator and quick learner
  • Strong communication skills (verbal and written) and presentation skills

All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

WHO WE ARE:

Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.

We don’t think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.

We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.

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