Principal Scientist/Associate Director, 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 exceptional individual to join the team as Clinical Pharmacologist. Reporting to the Director of Clinical Pharmacology, this individual will be responsible for providing strategic and operational clinical pharmacology and PK support to project teams. The candidate will possess an in-depth understanding of clinical pharmacology and have experience designing and executing studies, critically analyzing and reporting clinical pharmacology results for submission.
- Provide strategic clinical pharmacology guidance to cross functional project teams. Work with clinical development and/or program teams to achieve program goals and provide deliverables in approved timeframes.
- Drive the development and execution of clinical pharmacology strategy and 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 and oversee clinical study conduct. Contribute to statistical analysis plans, clinical study reports, responsible for data review/analysis, interpretation and reporting.
- Lead the analysis, interpretation and reporting of clinical PK & PD data and develop model-based justifications for optimal dose selection for pivotal clinical trials
- Identify and manage consultants and vendors supporting clinical pharmacology activities, e.g. bioanalysis, PK analysis, metabolite profiling & identification, Population PK, etc. Provide scientific input, monitor work to ensure compliance with agreed protocols, quality standards and timelines. Review external data/study reports.
- Responsible for clinical pharmacology and clinical PK sections of regulatory and clinical submission documents. Represent Blueprint in interactions with regulatory authorities; take the lead in addressing DMPK and clinical pharmacology related regulatory queries.
- PhD or PharmD in Clinical Pharmacology, Pharmacokinetics or a related field with minimum 5 years of bio/pharmaceutical industry experience as a clinical pharmacologist.
- Strong knowledge of pharmacokinetics and modeling, PK/PD principles, ADME concepts, bioanalytical principles, and global regulatory clinical pharmacology requirements to support clinical development
- Demonstrated ability to manage the clinical pharmacology/pharmacokinetic components of projects
- Demonstrated experience in authoring, presenting, and discussing nonclinical and clinical pharmacology data with stakeholders, including regulatory authorities
- Proficient in using Phoenix/WinNonlin, NONMEM, R and/or other pharmacokinetic modeling software
- Ability to work effectively and collaboratively on cross functional project teams, in a fast-paced, dynamic environment under tight timelines
- Exceptional project management and people skills, ability to quickly grasp complex concepts
- A team player, effective listener, clear communicator and quick learner
- Strong communication (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.