Postdoctoral Research Fellow, Blueprint--Clinical Scientist
Northeastern UniversityAbout the role
About the Opportunity
About the Opportunity:
Northeastern University’s Pharmaceutical Industry Fellowship Program is a two-year fellowship designed to advance the education and training of Pharm.D. graduates in various areas of industry pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas. The program is a collaboration between Northeastern University and biopharmaceutical industry partners.
In partnership with Northeastern University, Blueprint Medicines is offering a two-year Clinical Scientist PharmD fellowship based in Cambridge, MA.
About Blueprint Medicines:
Blueprint Medicines will offer three 2-year Fellowship Programs in collaboration with Northeastern University designed to offer Doctor of Pharmacy graduates an in-depth experience in a biopharmaceutical industry setting. Blueprint Medicines is a global precision therapy company striving to improve human health. With a focus on genomically defined cancers, rare diseases and cancer immunotherapy, we combine our leading expertise in protein kinases with a uniquely targeted, scalable approach to empower the rapid design and development of transformational medicines.
Responsibilities:
The Clinical Scientist fellowship at Blueprint Medicines will offer an opportunity for you to develop a proficient understanding of Clinical Development by involving you in the conduct of clinical studies, including clinical development plans, study design and feasibility, and data collection and analysis. Throughout the fellowship, you will engage in projects to develop a deep scientific clinical data knowledge and gain valuable clinical trials development experience. Our program is designed to expose you to multiple departments and cross functional teams. In your first year, you will work as a clinical scientist on projects that are at different stages of clinical development and contribute to longitudinal projects. In your second year, you will have the opportunity to rotate based on your preferences, through different departments in Clinical Development (examples include Clinical Operations, Clinical Pharmacology, Pharmacovigilance and/or Translational Research) as well as in other areas of expertise outside clinical development according to your interests. The intent of this program is to train you in across different Clinical Development functions and build a foundation for clinical trials development from an operational, technical, and scientific point of view.
Key workstreams may include:
• Work closely with Medical Directors, Pharmacology, Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols.
• Development and review of key study documents, including protocol, Investigator Brochures, Inform Consent Forms and other clinical documents including training and meeting material.
• Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety and assist in communicating a clear overview of trial results.
• Support safety and medical data monitoring and review in preparation for safety and efficacy review meetings.
• Reporting of study results and reviewing and summarizing relevant literature.
• Collaborate with cross-functional department (Including data management, translational research) in the analysis, and reporting of clinical information.
• Contribute to the preparation, and execution of investigato
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