The Clinical Sciences and Innovation (CS&I) department in NIBR Translational Medicine is a dynamic group of clinical scientists responsible for the conduct and evaluation of Phase I and Phase IIa clinical studies. These studies are designed to profile safety, tolerability, pharmacokinetics, and pharmacodynamics and to provide early proof of efficacy of novel compounds in humans. CS&I in Cambridge, MA, specializes in early clinical research in diabetes, cardiovascular and metabolic conditions, ophthalmology, neuroscience, respiratory, and infectious diseases. Globally, CS&I also performs clinical research in autoimmunity, musculoskeletal disorders, dermatology and transplantation. Over 100 clinical sciences experts in multiple CS&I locations worldwide strive to provide a smooth transition from discovery research to clinical practice and enable potential medicines to be tested more effectively in humans.
Over the course of the Fellowship, the Fellows will:
Lead and participate in the clinical trial team to impact study design, conduct and analysis
Develop clinical trial protocols
Contribute to the design of data capture tools and statistical analysis plans
Create and obtain essential regulatory trial documents
Orchestrate operational aspects of clinical trials including selection and oversight of clinical trial centers and external vendors
Participate in the analysis of study data and the preparation of final study reports
Contribute to writing of Investigator’s Brochure, briefing books and safety updates
Understand and comply with Good Clinical Practice (GCP) and regulatory requirements
Learn to work cross-culturally with colleagues and study sites around the world
“In addition to your application in PPS, please visit the MCPHS application portal to initiate your formal application http://www.mcphs.edu/pharmdfellow. For each position you request an interview for at PPS, please select it on the portal. Application materials must be received by December 20th.”
Interested individuals should request an interview through the PPS Portal.
In order to be considered for an interview at Midyear, the following should be submitted through the PPS Portal:
Updated Curriculum Vitae
Letter of Intent stating your interest in the NIBR Fellowship and working with clinical trials
The deadline for requesting an interview and submitting these materials is November 27, 2017.
*Early submission is recommended due to limited interview slots. Interviews will be scheduled on a first-come, first-serve basis.
2 openings. Employer will assist with relocation costs.
Additional Salary Information: Fellows will receive a competitive stipend and benefits package, including comprehensive health insurance.
About MCPHS University/Novartis Institutes for BioMedical Research
The Novartis Institutes for BioMedical Research (NIBR) is the global pharmaceutical research organization for Novartis. We are committed to discovering innovative medicines to treat diseases with high unmet medical need. With more than 6,000 scientists and physicians around the world, our open and entrepreneurial culture encourages collaboration as we work to push the boundaries of science to change the practice of medicine.